News
Amylin, Lilly gear up for big FDA ruling
Eli Lilly, Amylin and Alkermes will be holding their collective breath this Friday when the FDA will reveal whether it will approve Byetta LAR, the long-acting form of the bestselling diabetes drug Byetta. Thanks to technology from Alkermes that helps the drug stay in the patient's bloodstream, Byetta LAR can be administered just once a week rather than requiring twice-daily injections.
What's at stake for these companies? Amylin has the most invested. An approval could provide the drugmaker with billions in revenues for years to come. According to the Wall Street Journal, one analyst projected $2.1 billion in sales for the drug by 2015, while another industry watcher predicts $3 billion in U.S. sales. For Lilly, Byetta LAR would boost a product lineup that's facing one of the steepest patent cliffs in the coming years. And Alkermes is set to reap 7.5 percent royalty on worldwide sales.
Xconomy's Luke Timmerman maps out the four possible outcomes from the FDA's decision Friday:
- The FDA approves Byetta LAR with only a standard warning, though JP Morgan analyst Cory Kasimov says there's not much chance of that happening.
- Byetta LAR could be approved, but with a severe black box warning about the possibility of patients developing thyroid cancer.
- Third--most likely, according to Kasimov--the FDA will delay its response and ask for additional, but minor, data on the drug. In that case, the companies could still have an approval in hand by the end of 2010.
- Finally, the worst-case scenario: FDA could issue a "complete response" letter asking for major new set of data that would severely delay the drug's approval. If that happens, look for Amylin stock to lose half its value and Alkermes to dive about 33 percent.
Needless to say, the stakes are high for all involved.
- here's the Wall Street Journal report
- read more from Xconomy
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Cytokinetics gets orphan drug status for ALS drug
Cytokinetics announced today that its drug CK-2017357 has been granted orphan-drug designation by FDA. The drug is in trials for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease), a condition that affects about 20,000 to 30,000 people in the U.S. Cytokinetics plans to initiate a Phase II trial for CK-2017357 in ALS patients in the first half of 2010. Cytokinetics release
Neuropharm mulls voluntary liquidation as it waits for deal
Shares of U.K.'s Neuropharm shot up 33 percent this morning when the developer announced that its board will explore the possibility of a return of cash to shareholders. The company is still hoping to pull off a deal for its lead autism candidate NPL-2008, which it put up for sale in November of last year. "The company is continuing talks with a potentially interested party, which is in the advanced stages of due diligence, but no indicative offer has yet been received from that party," Neuropharm says in a statement.
Neuropharm's shares took a beating early last year after the biotech reported that its late-stage trial for an experimental autism therapy flunked its primary endpoint. But its stock was revived upon rumors that it was getting close to a deal for NPL-2008. In its release, the company notes it has significantly reduced its cash burn and had £6.18 million ($9.2 million) on hand as of Dec. 31, 2009.
- here's Neuropharm's release
- read this Reuters report for more
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EKR names interim president, CEO
> EKR Therapeutics has announced that its executive chairman John Bailye has been appointed interim president and CEO replacing Howard Weisman, who is no longer with the company. Weisman will also no longer serve on EKR's board of directors. Release
> Human Genome Sciences has named David Southwell as CFO and EVP. Release
> Robert Shepard has been appointed CMO of Cornerstone Pharmaceuticals. Release
> Shengtai Pharmaceutical has appointed Hu Ye as its new CFO. Release
> Talaris Advisors has named Derek Lee as CFO and corporate development officer. Release
> Sandoz announced the appointment of Don DeGolyer as president of the company's U.S. operations and head of commercial operations for North America.
> Phillip Frost will serve as the new chairman of the board of Teva Pharmaceutical Industries after Eli Hurvitz indicated he wishes to be released from his duties. Moshe Many has stepped down from his role as interim chairman and has been appointed vice chairman. Release
> Protalix BioTherapeutics has reported that Eli Hurvitz is relinquishing his position as chairman and member of the board of directors. The board has unanimously appointed longstanding member Zeev Bronfeld to serve as interim chairman. Release
> Charles Lannon has been named vice-chairman of the board at Kinex Pharmaceuticals. Release
> China Yongxin Pharmaceutical has announced that Hal Lieberman, Laura Philips, Bing Li and Jingang Wang were appointed to its board of directors as independent directors. Release
> 3SBio has announced changes to its board of directors. Liping Xu, company founder, executive director and VP, will retire from the board and her position as a company officer. Peiguo Cong will join the board and serve as an independent, non-executive director.
Novartis offers $955M deal to snare Transgene drug option
Novartis has put up $10 million and promised up to €700 million more in milestones in exchange for an option on Transgene's promising, late-stage cancer immunotherapy.
France's Transgene will hold on to control of the upcoming Phase IIb/III pivotal trial of TG4010 that is slated to get under way by the end of this year after enrolling about a thousand patients with non-small cell lung cancer. Once Novartis gets its hands on the IIb portion of the data, the pharma giant will have 90 days to decide whether it will exercise its option on the program. The data is scheduled to arrive in early 2012.
If Novartis decides to pull the trigger on the option--a deal structure that is growing increasingly common in drug development--Transgene will get a fee plus milestones along with co-promotion rights in a list of countries that includes France and China. Novartis will gain control of the program and take responsibility for further costs.
"We believe this agreement represents the best way to accelerate development and create long term value for our shareholders," says Transgene CEO Philippe Archinard. "It is also consistent with the company's goal of becoming a fully integrated biopharmaceutical company as under this agreement Transgene will maintain certain commercialization and manufacturing rights."
However, not everyone was impressed with the optional, uncertain terms of the agreement, andshares in the French biotechnology company went down 12 percent. "We view today's option announcement as slightly underwhelming, given that the ongoing burden of funding remains with Transgene for another two years," says Nomura Code analyst Gary Waanders.
Because Novartis wants to see the outcome of a mid-stage Phase IIb clinical trial before exercising its option, Waanders said he was reviewing his "neutral" rating and fair value estimate of 21.80 euros a share.
- check out the Transgene press release
- here's the Reuters story
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Biotech VCs, Big Pharma stepping outside the comfort zone
BARCELONA - On Monday evening I moderated a panel on corporate venture financing at BIO-Europe Spring, joined by Roel Bulthuis, the head of Merck Serono Ventures, Anja (it's pronounced Anya) König, managing director of Novartis Venture Fund, Patrick Krol, a partner with Aescap and Malcolm Weir, the CEO at Heptares. I'd spoken with Weir before about his U.K. biotech company and knew that he and König went back. Novartis is an investor in Heptares, which we featured last year as a Fierce 15 company.
König's fund has a history of getting in early at a developer. And as she emphatically hammered home during the rather informal hour-long exchange about corporate VC goals and objectives, Novartis' venture arm is on the lookout for game-changing technologies. An incremental, short-yardage health gain isn't the objective.
Over the last year, König's longstanding interest in the cutting-edge has become an increasingly common feature in the drug development scene. As Big Pharma companies apply shock therapy to their R&D empires, it's clear that the top CEOs are focused on getting their organizations to think more like biotech organizations. If they can't become more efficient at development and shed some of the bureaucracy that has grown around their empires even as they grow bolder in their scientific objectives, then they won't be nimble enough to get out from under the avalanche of patent expirations that is tumbling their way. That process won't ever be pretty, but it is understandable.
That's a lesson, though, that more biotech execs need to take to heart as well. Safety is great. Low risk is great--if you can find it, and I'm not sure you can. But if you aren't trying to change the game of health, it's going to be very difficult to find a licensing partner when you need one. Getting backing from a venture group that thinks that way is the best kind of validation you can hope for as you're going into the clinic.
Thanks to everyone on the panel for a lively discussion. And we appreciated a big, receptive audience. Moving from the world of virtual, online news production to the world of face-to-face communication helps make simple truths come alive. - John Carroll twitter | email
More from BIO-Europe:
'Externalization' takes center stage at Bio-Europe Spring
The biotech spring arrives in Barcelona
In 9-3 vote, expert panel backs InterMune's pirfenidone
An FDA expert panel voted 9-3 Tuesday in favor of InterMune's Esbriet (pirfenidone), a treatment for idiopathic pulmonary fibrosis. IPF is a rare and fatal lung disease that affects approximately 200,000 people in the U.S. and Europe. If approved, Esbriet would be the first treatment for U.S. IPF sufferers. The treatment has already received approval in Japan on the condition that there will be a post-marketing period during which the drug won't be widely available until further data are available.
Not all the panelists were convinced of the drug's efficacy; however, most voted that the potential benefits of the drug outweighed these concerns. "I voted yes because I've been straight down the middle the entire time. I didn't see substantive evidence of efficacy per the FDA regulations but there was clinical meaningful effect on the disease. You need to offer patients hope. If this offers a smidgen of hope, then it is worth approving," one panelist said, according to TheStreet's Adam Feuerstein. Added another, "I voted yes, opposite of my vote on the question of substantial efficacy because I don't believe there is substantial evidence of efficacy; but if I got this disease, I'd be on the next Delta flight to Japan."
The FDA doesn't have to follow the panel's recommendations, but it usually does. In a conference call, CEO Dan Welch said that if the drug is approved, it may take the company some time to ramp up production. "We chose not to make certain investments in commercial or other areas of the company until we had visibility from this meeting. So one should not expect that Esbriet would be available immediately after the approval."
During the call, analysts also attempted to suss out how InterMune would price the biologic if approved. InterMune also manufactures Actimmune, a treatment for chronic granulomatous disease that's been used off-label for the treatment of IPF. On-label, Actimmune runs in the range of $8,000 to $20,000 per year. When used off-label for IPF patients, the annual cost price per year shoots up to $50,000. "I don't know what you draw from that," noted Welch, unwilling to reveal the possible price of Esbriet. A final decision is expected May 4.
- check out InterMune's release
- read TheStreet's live blog on the panel meeting
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Abbott buys Facet Biotech for $450M
Abbott has succeeded where Biogen Idec once failed. The company announced late Tuesday that it's purchasing Facet Biotech for $450 million, or $27 a share. That's 67 percent premium over the biotech's closing price of $16.21 earlier today.
Abbott says the acquisition will boost its early- and mid-stage pharmaceutical pipeline. The developer has its eyes on two primary therapeutic areas--immunology and oncology. The highest-priority program is daclizumab, a Phase II biologic for multiple sclerosis that will move into Phase III trials in Q2 of 2010. Facet is already partnered with Biogen Idec on the compound. The biotech also has oncology compounds for multiple myeloma and chronic lymphocytic leukemia in early to mid-stage trials.
Last year Biogen attempted to purchase Facet, eventually making a "best and final offer" of $430 million after its initial $356 million bid was deemed hopelessly unrealistic based on the developer's cash position and pipeline. But with the support of two major investors, Facet was able to fend Biogen off, while at the same time noting that it would be open to more substantial bids from other companies. Biogen will owe Facet a big milestone on the launch of a late-stage study for daclizumab.
"This acquisition will further strengthen Abbott's biologics capabilities and pharmaceutical pipeline," says John Leonard, M.D., senior vice president, global pharmaceutical research and development, Abbott. "Daclizumab is a promising treatment for multiple sclerosis, a disease that has a significant unmet medical need, and has the potential to become an important treatment option for patients. We continue to explore multiple mechanisms to treat autoimmune diseases and cancer with both biologic and small molecule approaches."
Abbott has been on a buying spree as of late. It spent $10 billion on new acquisitions last year, paying $3 billion for Advanced Medical Optics and $6.6 billion for the prescription drug business of Solvay.
- here's Abbott's release
- read the BusinessWeek article for more
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University of California, San Diego (UCSD) Study Shows Potential for Using Algae to Produce Human Therapeutic Proteins
Abbott Laboratories to Buy Facet Biotech for $722 Million
ABBOTT PARK, Ill. and REDWOOD CITY, Calif., March 9 /PRNewswire-FirstCall/ -- Abbott (NYSE:ABT - News) and Facet Biotech Corporation (Nasdaq:FACT - News) announced today a definitive agreement for Abbott to acquire Facet, enhancing Abbott's early- and mid...
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