surf1944
12 years ago
5:56AM Amylin Pharma to be acquired by Bristol-Myers Squibb (BMY) for $31.00/share or $5.3 bln; AstraZeneca (AZN) will make a payment to AMLN for $3.4 bln in cash; expected to be dilutive to BMY's FY2012 & 2013; slightly accretive by 2014 (AMLN) 28.22 +0.17 : BMY and AMLN announced that BMY will acquire AMLN for $31.00 per share in cash, pursuant to a cash tender offer and second step merger, or an aggregate purchase price of ~$5.3 bln. The total value of the transaction, including Amylin's net debt and a contractual payment obligation to Eli Lilly (LLY) together totaling about $1.7 bln, is ~$7 bln. The acquisition has been unanimously approved by the boards of directors of Bristol-Myers Squibb and Amylin. The board of directors of Amylin has unanimously recommended that Amylin's stockholders tender their shares into the tender offer.
Bristol-Myers Squibb and AstraZeneca (AZN) announced today that, following the completion of Bristol-Myers Squibb's acquisition of Amylin, the companies will enter into collaboration arrangements, based on the framework of the existing diabetes alliance, regarding the development and commercialization of Amylin's portfolio of products. Following completion of Bristol-Myers Squibb's acquisition of Amylin, AstraZeneca will make a payment to Amylin, as a wholly owned subsidiary of Bristol-Myers Squibb, in the amount of ~$3.4 bln in cash. Profits and losses arising from the collaboration will be shared equally. In addition, AstraZeneca has the option, exercisable at its sole discretion following the closing of the acquisition, to establish equal governance rights over key strategic and financial decisions regarding the collaboration, upon the payment to Bristol-Myers Squibb of an additional $135 mln. These collaboration arrangements have been approved by the boards of directors of Bristol-Myers Squibb and AstraZeneca.
Under the terms of the definitive merger agreement between Bristol-Myers Squibb and Amylin, Bristol-Myers Squibb will commence a cash tender offer to purchase all of the outstanding shares of Amylin's common stock for $31.00 per share. The merger agreement contains a provision under which Amylin has agreed not to solicit any competing offers for the company. Bristol-Myers Squibb will finance the acquisition from its existing cash resources and credit facilities. For Bristol-Myers Squibb, the transactions are expected to be dilutive to Non-GAAP earnings per share (EPS) in 2012 and 2013 by ~$0.03, becoming slightly accretive starting in 2014 with meaningful accretion expected in the later part of the decade. The estimated Non-GAAP EPS impact excludes amortization of acquired intangible assets, restructuring costs and other costs associated with the transactions.
AMLN stated "We are pleased to be able to strengthen the portfolio we have built to help patients with diabetes by building on the success Amylin has had with its GLP-1 franchise. The acquisition of Amylin by Bristol-Myers Squibb is also a unique way for Bristol-Myers Squibb and AstraZeneca to expand the alliance between the two companies, and it demonstrates Bristol-Myers Squibb's innovative and targeted approach to partnerships and business development."
surf1944
13 years ago
8:13AM Amylin Pharma: Carl Icahn confirms that he has issued an Open Letter to the Board of Directors of AMLN says 'believes any decision not to pursue a sale of the company at this time is a huge mistake' (AMLN) 24.11 : Icahn stated "As one of Amylin's largest shareholders, I find it reprehensible that the Board of Directors has still not acknowledged or denied the media reports regarding its rejection of a $22 per share takeover offer from Bristol-Myers Squibb (BMY). To this day, shareholders would not have known about this opportunity had the story not been leaked to the press. Still more egregious is the fact that, in the face of this reported $22 offer, the Board approved both (i) the public offering of 10% of the company at an assumed price of $15.62 per share on March 8th, without disclosing the Bristol-Myers offer in the registration statement that Amylin filed with the SEC..These actions make absolutely no sense to me in light of a Bristol-Myers bid and have served to substantially dilute shareholders who owned the stock when these actions were taken. I believe any decision not to pursue a sale of the company at this time is a huge mistake... I believe these nominees have been a positive force for change, but apparently their influence has not been enough to keep this Board from mishandling a Bristol-Myers proposal. In light of the failings mentioned above, it seems to me that the current Board is still dysfunctional and is not operating in a manner that enhances shareholder value... number of analysts in the investment community agree that the company faces daunting prospects in fully realizing the value of its products as an independent firm....Further, we delivered to Amylin on Tuesday a demand under Section 220 of the Delaware General Corporation Law for copies of Amylin's books and records, so that we may examine the circumstances surrounding the reported Bristol-Myers Squibb proposal and the stock offering and option grants following the date of the reported bid. These are matters that, in my opinion, shareholders are entitled to fully understand...In my view, a proxy contest at this time would be a costly distraction -- but I would not shy away from that possibility if I felt that the Board was not pursuing seriously the opportunity to sell the company.
mlkrborn
13 years ago
History repeating? First down from 20 to 10 than sale @$22. Sme argue it is a rip off deal.
1. Amylin shares rocket up on report of $3.5B buyout offer by Bristol-Myers
By John Carroll
Shares of Amylin Pharmaceuticals ($AMLN) rocketed up 45% this morning, fueled by a report by Bloomberg that the Bydureon developer had turned a cold shoulder to a $22 per share buyout offer from Bristol-Myers Squibb ($BMY), putting the value on this new potential pearl at $3.5 billion.
Amylin has had an eventful schedule over the past year. First it sued its longtime partner Eli Lilly ($LLY) after Lilly forged a marketing pact with rival Boehringer, then it executed an expensive divorce from the pharma giant. Soon after, the FDA delivered on a long-awaited approval for Bydureon, the once-weekly successor to the Byetta franchise. Now Meg Tirrell and Jeffrey McCracken, quoting sources close to the deal, report that Amylin rejected Bristol-Myers offer to pay a 43% premium to buy the company--a deal that would register as the largest in a string of 19 BMS acquisitions over the past five years.
As Bloomberg notes, Amylin has been seeing its revenue from Byetta shrink as Novo's ($NVO) Victoza muscled into its market share. And it's been looking for a global partner who can step into Eli Lilly's shoes outside the U.S. But none of that persuaded Amylin to warm up to Bristol-Myers' offer. BMS hasn't been back in touch since it was rejected by Amylin.
Amylin struck a $1.6 billion deal to end its relationship with Lilly. That included a $250 million upfront and a $1.2 billion share of the Bydureon revenue. The FDA's approval came soon after the two companies split up.
News of the $3.5 billion bid quickly seized the attention of Wall Street analysts, who began to debate just what Amylin is worth. Its value has a lot to do with its prospects for Bydureon, of course, and as Adam Feuerstein at TheStreet notes, if the board is turning down a $22 offer, they must have a strong belief that they can go on to register blockbuster sales. But if Bristol can't prevail, adds Feuerstein, the likes of Takeda, GlaxosmithKline and AstraZeneca just might step in.
- here's the story from Bloomberg
- here's the report from TheStreet
Docsfixinit
13 years ago
FDA Approves BYDUREON(TM) -- The First and Only Once-Weekly Treatment for Type 2 Diabetes
Last update: 1/27/2012 3:39:00 PM
Provides Glycemic Control in a Once-Weekly Dose
SAN DIEGO and DUBLIN, Jan. 27, 2012 /PRNewswire via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN) and Alkermes plc (ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON(TM) (exenatide extended-release for injectable suspension) - the first once-weekly treatment for type 2 diabetes. BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. BYDUREON will be available in pharmacies nationwide in February.
To view the multimedia assets associated with this release, please visit:
"With BYDUREON, U.S. physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control."
The approval of BYDUREON (pronounced by-DUR-ee-on) was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with BYDUREON resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with BYETTA® (exenatide) injection, a twice-daily form of exenatide that has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. BYDUREON uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide.
"As the first and only once-weekly diabetes treatment, BYDUREON represents an important milestone in Amylin's promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "BYDUREON builds upon the proven benefits of BYETTA, offering significant improvements in glycemic control in a single weekly dose."
In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, patients taking once-weekly BYDUREON experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking BYETTA. A1C is a measure of average blood sugar over three months. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking BYDUREON and 3.0 pounds for patients taking BYETTA (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by BYDUREON users (14 percent) than by BYETTA users (35 percent). Other common treatment-emergent adverse events in the BYDUREON group included diarrhea, upper respiratory tract infection and injection site nodules. There were no major hypoglycemic events.
BYDUREON has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of BYDUREON outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of BYDUREON on medullary thyroid cancer and cardiovascular disease. More information will be available at .
BYDUREON is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. In the DURATION clinical studies, the delivery system was well accepted by patients and physicians.
mlkrborn
13 years ago
AMLN $9.60 with "Blockbuster breakup: Amylin buys out Lilly's exenatide rights in $1.6B deal
By John Carroll FierceBiotech
The decade-long union of Amylin ($AMLN) and Eli Lilly ($LLY) on the diabetes front ended in a blockbuster breakup today, with Amylin agreeing to pay Lilly $250 million upfront and up to $1.2 billion from the sales of exenatide products in exchange for full rights to the drug and its successors.
The divorce was presented today as an amicable ending to a long and fruitful partnership, but Amylin has been acting anything but amicably over the course of the year. The biotech filed suit against Eli Lilly earlier this year after the pharma giant joined forces with Boehringer Ingelheim, a rival in the diabetes field, on Trajenta. Today's agreement also ends the litigation.
Under the terms of the deal, Amylin will hand over a $1.2 billion secured note to Lilly, paying it off with the sales revenue from exenatide products. But if the FDA still hasn't approved the once-weekly injectable Bydureon--the successor to Byetta--by mid-2014, then the revenue sharing deal will terminate and Lilly's share of the sales revenue will shrink from 15% to 8%. FDA approval of a once-monthly version of the drug, now in mid-stage development, would trigger a $150 million milestone payment. Transitioning worldwide commercialization and development of new exenatide products starts in the U.S. at the end of this month then rolls around the globe by the end of 2013.
"Lilly remains confident that the resubmission package for Bydureon has addressed the requirements outlined by the FDA and looks forward to Amylin achieving the alliance's long-held goal of making Bydureon available to patients in the U.S.," said Enrique Conterno, president of Lilly Diabetes. "Looking forward, Lilly Diabetes remains committed to providing a comprehensive portfolio of diabetes treatment options for patients through our currently marketed products and robust clinical pipeline."
Alkermes, which has a royalty stake in the success of Bydureon, will evidently stay with Amylin now that the two big partners have severed their union."
source: FierceBiotech
surf1944
13 years ago
Amylin, Alkermes say diabetes drug safe for heart
Amylin and partners say weekly diabetes injection does not affect heart activity
On Thursday July 7, 2011, 6:55 pm EDT
WASHINGTON (AP) -- Shares of Amylin and Alkermes Inc. climbed Thursday after the companies said their once-per-week diabetes medication appears safe for the heart, addressing concerns that delayed its federal review last year.
The drug, Bydureon, is designed to be a next-generation version of the twice-daily injection Byetta, which is currently marketed by Amylin and Eli Lilly & Co. Inc. Alkermes, based in Waltham, Mass., created the technology that gradually releases the drug over the course of a week.
The Food and Drug Administration declined approval for Bydureon in October, saying more information on its effect on the heart was needed.
The companies said a 75-patient study of Bydureon showed it did not interfere with the electrical activity of the heart even at high doses, a key safety measure in drug trials.
"We are confident in these results and will continue to work toward making Bydureon available to patients in the U.S. as soon as possible," said Christian Weyer, senior vice president at Amylin Pharmaceuticals.
Bydureon is part of a new wave of diabetes treatments designed to treat the rising epidemic of the disease in the U.S. However, the FDA has raised safety standards for such treatments after GlaxoSmithKline's blockbuster diabetes pill Avandia was linked to heart attack risks.
New drugs that have already reached the market include Merck & Co.'s Januvia and Bristol-Myers Squibb Co. and AstraZeneca's Onglyza. Those drugs are technically in a different class from Bydureon but work with the same goal of controlling blood sugar levels.
Regulators for the European Union approved Bydureon last month.
Lilly is based in Indianapolis, and Amylin is headquartered in San Diego.
Shares of Amylin Pharmaceuticals Inc. rose $1.44, or 10.5 percent, to $15.15 in afterhours trading. Alkermes tacked on $1.17, or 6 percent, to $20.40. Lilly was unchanged.
surf1944
13 years ago
Once-Monthly Exenatide Improved Glucose Control in Patients with Type 2 Diabetes: Phase 2 Study Results Presented at ADA 2011
Majority of Patients Reached the ADA Treatment Target for Glycemic Control
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Press Release Source: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc. On Friday June 24, 2011, 5:00 pm EDT
SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News), Eli Lilly and Company (NYSE:LLY - News) and Alkermes, Inc. (Nasdaq:ALKS - News) today announced additional results from a phase 2 study of an investigational, once-monthly injectable suspension formulation of exenatide which showed substantial improvements in glycemic control, including reductions in A1C and fasting plasma glucose, with modest weight loss. These findings will be presented in a late breaking poster session at the 71st Scientific Sessions of the American Diabetes Association on Sunday, June 26 from 12-2 p.m. PDT.
The 121-patient study assessed the efficacy, safety and tolerability of three different doses (5 mg, 8 mg and 11 mg) of exenatide once monthly, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. After 20 weeks of treatment (total of five injections), patients receiving exenatide once monthly experienced average improvements in A1C (a measure of average blood sugar over three months) from baseline of 1.3 percentage points for the 5 mg and 8 mg doses and 1.5 percentage points for the 11 mg dose. In addition, 50 percent of those treated with the 5 mg dose, 57 percent treated with the 8 mg dose and 70 percent treated with the 11 mg dose achieved an A1C of less than 7 percent, the ADA-recommended target for good glucose control. Patients also lost a modest amount of weight (0.9 pounds with the 8 mg dose and 2.4 pounds with the 5 mg and 11 mg doses), although exenatide once monthly is not being studied as a weight-loss product. Fasting plasma glucose was improved with all doses, with reductions of 25 mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL with the 11 mg dose. The mean pharmacokinetic profile showed all three exenatide once monthly doses resulted in steady-state exenatide plasma levels within the known therapeutic range.
As a reference arm, the study also included patients receiving BYDUREON™ (exenatide extended-release for injectable suspension), another investigational form of exenatide that is dosed once-weekly. Results for A1C, fasting glucose and weight in the exenatide once monthly treatment arms were generally comparable to those seen in the BYDUREON reference arm. Patients receiving BYDUREON experienced reductions in A1C (1.5 percentage points), fasting plasma glucose (34 mg/dL) and weight (3.1 pounds) compared to baseline.
"Our exenatide suspension program builds upon our extensive experience and knowledge gained throughout the development of BYETTA and BYDUREON, and suggests promise in harnessing the therapeutic potential of continuous GLP-1 agonism in a monthly dose," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "We are committed to expanding the treatment options available to patients living with type 2 diabetes through the continued investigation of additional formulations of exenatide."
More than 90 percent of patients completed the study. The most common adverse events within the exenatide once monthly treatment groups were headache (17-27 percent) and nausea (17-23 percent). Headache (30 percent) and diarrhea (27 percent) were most common among the BYDUREON group. No major or minor hypoglycemia was reported in the study. The duration of adverse events was generally similar between treatment groups.
Exenatide once monthly is an investigational, extended-release formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same microsphere technology used in BYDUREON. BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension, an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON received marketing authorization in the European Union earlier this month.
Study Design
This phase 2, randomized, open-label, dose-ranging study included 121 adults with type 2 diabetes (baseline A1C: 8.6 percent for BYDUREON and 8.4-8.5 percent for exenatide once monthly) who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos® (pioglitazone) or both. Subjects were randomized to receive either 2 mg weekly subcutaneous injections of BYDUREON or subcutaneous injections of exenatide once monthly at a low (5 mg), medium (8 mg) or high (11 mg) dose administered once every four weeks for 20 weeks.
About Diabetes
Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide.(i)(ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs more than $174 billion per year in direct and indirect medical expenses.(iii)
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi)(vii)
surf1944
13 years ago
The Diabetes Trade: Why We Like Amylin
In my recent manifesto about diabetes, I briefly touched upon Amylin Pharmaceuticals (AMLN). As most readers are aware, Amylin focuses the majority of its R&D on drugs for type 2 diabetes and obesity.
We believe that Amylin's pipeline could fit in with well with that of several large pharmaceuticals. Many drug companies have been cutting back on R&D and intend to make further cuts in the upcoming years. It all boils down to a risk-reward dynamic. Big pharma may determine that it is more cost effective to look elsewhere for future products rather than to try to keep developing them on their own. Amylin’s current drugs are Symlin, used to treat both type 1 and type 2 diabetes, and Byetta, which treats just type 2 diabetes.
Byetta is Amylin's flagship drug, and comprises more than 80% of its revenues. The only problem is that Byetta is expected to come off patent in 2013. Amylin is currently developing other versions of Byetta. These phase II and phase III trials are determining if the efficacy of the drug can be used in alternative delivery and dosing methods, respectively. The revamped Byetta line in the later trial stages should most likely win approval based on the fact that they are reformulated versions of existing drugs.
There are several large pharmas that may have an interest in Amylin. We believe that Eli Lilly (LLY), a current partner, is the most likely winner. Of the other companies interested, including Merck (MRK) and Pfizer (PFE), Pfizer is perhaps the more likely candidate, having recently been losing market share to two of the largest diabetes drug manufacturers, Sanofi-Aventis (SNY) and Novo Nordisk (NVO). Amylin's pipeline could give Pfizer much need market share in the diabetes sector of the industry. Pfizer has only one type 2 diabetes drug in phase II trials; the other nine are all in phase I.
Amylin’s market cap is around $2 billion and the stock trades for around $13 dollars a share. Revenues have declined 12% year over year, as other diabetes drugs have eaten into Amylin’s market share. Any type deal that involves a small biotech-pharma is always risky, and trials may have to progress further before another company is comfortable enough to pull the trigger. Carl Icahn's 10% stake in Amylin is another question mark that merits consideration. As an activist shareholder, his letter to the board was not unexpected to say the least. If Mr. Icahn has his way, he will either get the new management that he is seeking or will convince the powers that be to sell some or all of the company, thus unlocking Amylin's value.
There is little clarity on how this will ultimately shake out. Either way, Amylin will undergo a changing environment. We feel that between its precision execution on cost-cutting and the likelihood of approval on its new delivery methods for Byetta, Amylin could see $20 - $22 representing full value for the stock - a far cry from its all time high of $53.25 in August of 2007, but still a nice return from here.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
http://seekingalpha.com/article/277351-the-diabetes-trade-why-we-like-amylin?source=yahoo
Blutribe
14 years ago
Bloomberg article...possible buyout??....Lilly's Diabetes Setbacks May Spur Shopping Spree Beyond Amylin
By Catherine Larkin - Oct 22, 2010 4:18 PM ET
Eli Lilly CEO John Lechleiter
John Lechleiter, chairman, president, and chief executive officer of Eli Lilly & Co. Photographer: Jeff Kowalsky/Bloomberg
Eli Lilly & Co., under pressure to gain new products after setbacks this week with two diabetes drugs, may try to acquire its partner Amylin Pharmaceuticals Inc. or covet companies with more approved products.
With Amylin, Lilly would gain full control of the diabetes drug Byetta and a longer-acting version called Bydureon delayed Oct. 19 by U.S. regulators, said Seamus Fernandez, a Leerink Swann & Co. analyst. Lilly might try to acquire Cephalon Inc. or Endo Pharmaceuticals Inc. to expand its painkiller business, said Bill Tanner, an analyst at Lazard Capital Markets.
By 2013, Lilly loses patents on medicines responsible for almost half its revenue. The Bydureon rejection, which stalled a new revenue source for at least two years, was compounded Oct. 20 when the company halted tests on a second experimental diabetes medicine because it wasn’t effective. Lilly Chief Executive Officer John Lechleiter yesterday ruled out “large- scale combinations” while expressing interest in smaller deals.
“An outright acquisition of Amylin certainly could make sense” if Lilly thinks Bydureon will be approved, Fernandez said in a telephone interview from Boston. Amylin, based in San Diego, lost half its market value on Oct. 20 after the Food and Drug Administration requested a study of Bydureon’s effect on heart rhythm.
Amylin fell 18 cents, or 1.6 percent, to $11.30 at 4 p.m. in Nasdaq Stock Market composite trading, after a 46 percent plunge on Oct. 20. Indianapolis-based Lilly fell 10 cents to $35.40 in New York Stock Exchange composite trading.
40 Percent Premium
The average premium paid in the last 12 months for acquisitions of U.S. medical and biotechnology companies was 40 percent, according to data compiled by Bloomberg. That suggests Amylin may have cost $2.3 billion yesterday, excluding debt, compared with $3.4 billion before shares plunged this week. Lilly had $5.16 billion in cash to make deals as of June.
Other diabetes-drug developers led by Pfizer Inc. and Sanofi-Aventis SA, may also pursue Amylin at its bargain price, Fernandez said. Ray Kerins, a spokesman for New York-based Pfizer, the world’s largest drugmaker, didn’t return calls for comment. Jean-Marc Podvin, a spokesman for Paris-based Sanofi, said he doesn’t comment on market rumors.
“We are very satisfied with our current relationship with Amylin and their management team,” Mark Taylor, a Lilly spokesman, said yesterday in an e-mail.
Shareholder Value
“Executing our current business strategy, including working with the FDA to bring Bydureon to patients as quickly as possible, is the best way to increase value for our shareholders,” said Alice Izzo, an Amylin spokeswoman, in an e- mail.
While there is risk Amylin may be the target of an opportunistic acquirer, it’s not likely the company would solicit offers, said Howard E. Greene Jr., a co-founder who resigned from the board last year, in an Oct. 20 telephone interview.
“Whenever the stock gets whacked, you have to assume that some people are going to sharpen their pencils,” Greene said. “Two things happen: shareholders are mad, and companies with bundles of cash are standing on the sidelines, waiting for an opportunity.”
Lilly paid an undisclosed amount in July to buy closely held Alnara Pharmaceuticals Inc., the maker of a drug for pancreatic insufficiency. Lilly also said in March that it would pay an undisclosed amount to buy European rights to certain animal drugs from Pfizer and a manufacturing plant in Ireland.
‘Fundamental Strategy’
“Our fundamental strategy remains intact,” Lechleiter said during a conference call yesterday. “We’re not interested in large-scale combinations. I think there are many other opportunities that I think we could consider along the lines of several that we have done this year.”
Lechleiter’s plan to stick to small purchases or licensing deals won’t give investors much confidence, said Barbara Ryan, an analyst with Deutsche Bank in New York, in a telephone interview.
“A lot of those companies will just be adding to the pipeline and they’re not going to be something that the market will accrue much value to on Lilly,” Ryan said.
United Therapeutics Corp. may also be a good fit because Lilly has an 11 percent stake and the two companies are partnered on Adcirca, a lung treatment made from the ingredient in Lilly’s impotence pill Cialis, according to Fernandez. Forest Laboratories Inc. would be another option to complement Lilly’s research in antidepressants and arthritis medicines, he said.
‘Takeover Target’
“It is not our expectation that we’re an imminent takeover target for Eli Lilly,” said Andrew Fisher, a spokesman for Silver Spring, Maryland-based United Therapeutics, in a telephone interview. The 2008 Cialis marketing agreement prevents Lilly from attempting a takeover before 2014, he said.
Cephalon doesn’t comment on rumor or speculation, said Candace Steele, a spokeswoman for the Frazer, Pennsylvania-based company. Kevin Wiggins, of Chadds Ford, Pennsylvania-based Endo, also declined to comment as a matter of company policy. Frank Murdolo, a spokesman for New York-based Forest, didn’t return a telephone message for comment.
The patent expires next year for Lilly’s top-selling antipsychotic Zyprexa, which brought in $4.92 billion last year. Generic copies of the antidepressant Cymbalta and insulin product Humalog may be introduced in 2013. Had Bydureon been approved this week, it could have generated sales of $420 million next year, said Phil Nadeau, an analyst with Cowen & Co. in New York.
Tanner, of Lazard, estimates a fair price for Amylin would be as much as $15 a share, or about $2.16 billion based on 143.7 million shares outstanding as of June. He said Bydureon sales will be limited because there are at least six competing diabetes drugs in development -- including one from Lilly -- as well as one approved product, Novo Nordisk S/A’s Victoza.
“The chances that this drug makes it to market are probably pretty high, but you’re looking at almost two years from now,” Tanner said. “If it didn’t make it, then somebody would have massively overpaid for Amylin.”
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
mlkrborn
14 years ago
SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Oct 19, 2010 /PRNewswire via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide extended-release for injectable suspension).
In the complete response letter the FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol will be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. This letter did not cite any manufacturing processes referenced in the FDA's March 15 complete response letter. REMS and product labeling discussions will continue following submission of the additional data.
The companies' goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.
"We are committed to working closely with the FDA to resolve the issues raised in the complete response letter so that BYDUREON can be approved, and we can make this important treatment available to patients with type 2 diabetes as quickly as possible," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "We remain confident in BYDUREON based on the extensive exenatide database, including more than seven years of clinical experience with BYETTA, the twice-daily form of exenatide that is available in more than 60 countries worldwide."
BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA(R) (exenatide) injection. BYETTA has been available in the U.S. since June 2005 and is used in more than 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.
The NDA for BYDUREON was submitted in May 2009 and is based on data that include the DURATION-1 head-to-head clinical study, safety data from DURATION-2 and more than seven years of clinical experience with BYETTA. The agency issued a complete response letter to the companies in March 2010 and in May 2010 classified the companies' first complete response as a Class 2 resubmission with a PDUFA action date of October 22, 2010.
Amylin to Host Investor Conference Call
Amylin will host a conference call to discuss the complete response letter for BYDUREON at 4 p.m. PT on Oct. 19. Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals, will lead the call.
The call will be webcast live through Amylin's corporate website and a recording will be made available following the close of the call. To access the webcast, please log on to approximately 15 minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (800) 857-5738 begin_of_the_skype_highlighting (800) 857-5738 end_of_the_skype_highlighting (U.S./Canada) or (415) 228-4970 begin_of_the_skype_highlighting (415) 228-4970 end_of_the_skype_highlighting (international), conference access code 7487145. A replay of the call will also be available by phone beginning approximately two hours after the close of the call and can be accessed at (866) 375-1047 begin_of_the_skype_highlighting (866) 375-1047 end_of_the_skype_highlighting (U.S./Canada) or (203) 369-0288 begin_of_the_skype_highlighting (203) 369-0288 end_of_the_skype_highlighting (international).
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