Archive for November, 2009

This Week in Biotech: More Treats than Tricks

Thursday, November 5th, 2009

The last week of October was appropriately marked by treats and tricks. The stock market gyrated from investor ebullience over numbers showing a 3.5 percent growth of the U.S. GDP in the third quarter of 2009, to investor dismay over worries that a drop in consumer spending signals an unsustainable recovery. Meanwhile, life science companies were busy raising money and striking deals. Durham, North Carolina-based Aldagen (ALDH) took its place in a growing queue of companies hoping to go public in the coming months as the IPO window begins to open. The company, which develops regenerative cell therapies, had initially filed to go public in May of 2008 but withdrew those plans last October when the stock market crashed.
Now that the markets have strengthened, the company hopes to raise an estimated $80.5 million in an initial public offering to fund a phase 3 trial of its most advanced therapy for the treatment of critical limb ischemia, which can happen when a limb becomes damaged due to lack of blood flow. Aldagen also has a drug in a pivotal phase 3 trial for improving umbilical cord blood transplants used to treat inherited metabolic diseases in pediatric patients. Aldagen plans to list the shares on the NASDAQ Global Market under the symbol ALDH.
The world market for IPOs got a boost with the inauguration of the ChiNext exchange, a new Chinese stock exchange for small, high-tech enterprises, which started trading on Friday. All of the 28 listed companies, which included six involved in biotech and pharmaceuticals, soared in price on the first day of trading.
In the biggest deal of the week, Medivation (MDVN) will collaborate with Astellas Pharma (ALPMF.PK) to develop and commercialize MDV3100, a new generation of oral anti-androgen that is currently being evaluated in a phase 3 trial for the treatment of prostate cancer. In a deal similar to last year’s partnership between Medivation and Pfizer (PFE) for Dimebon in Alzheimer’s disease, the deal involves a significant amount of cash upfront and the option to co-promote the drug in the United States. Astellas will pay Medivation $110 million upfront and milestone payments up to $335 million as the candidate reaches certain development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. If and when the drug is approved, the companies will jointly commercialize MDV3100 in the United States, sharing equally in all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the United States and will pay Medivation tiered double-digit royalties on ex-U.S. sales.
Bay Area biotech SuperGen (SUPG) entered into a multi-year collaboration with GlaxoSmithKline (GSK) to discover and develop cancer therapeutics based on epigenetic targets in a deal that could be worth as much as $375 million for the epigenetics company. The deal is seen as validation for Supergen’s in-silico drug discovery platform. Under the terms of the deal, SuperGen will progress candidate compounds through to early clinical proof of concept. GlaxoSmithKline will then have the right to exercise an option to develop further and commercialize resulting products on a global basis. GSK will pay SuperGen $5 million upfront, which includes a $3 million common stock investment, priced at a premium to market. The deal includes the potential for development and commercial milestones, and double-tiered royalties.
Micromet (MITI) scored another hit on its BiTE antibody technology platform in a deal with Sanofi-Aventis (SNY). The companies entered a global collaboration and license agreement to develop a BiTE antibody against an antigen present at the surface of carcinoma cells. BiTE antibodies are novel therapeutic antibodies that activate a patient’s T cells to seek out and destroy cancer cells. Under this agreement, Bethesda, Maryland-based Micromet will be mainly responsible for the discovery, research and development of the BiTE antibody through the completion of phase 1 clinical trials after which Sanofi-Aventis will have full responsibility for the further development, as well as for the worldwide commercialization. Micromet gets $12 million cash upfront and is eligible for development and regulatory milestone payments of up to $241 million, plus performance-based sales milestones of up to $224 million and royalties on worldwide product sales.
Global contract research organization PPD (PPDI) is investing $100 million in Celtic Therapeutics Holdings, an investment partnership organized to acquire and develop novel mid-stage therapeutic candidates that address unmet medical needs, and advance development of these candidates to the next key product milestone, usually the beginning or end of phase 3. PPD’s investment is intended to set the stage for a strategic alliance between the companies with the goal of bringing the best products to market more quickly to meet unmet needs of patients.

Finally, Ligand Pharmaceuticals (LGND) is buying struggling Metabasis Therapeutics (MBRX) for the fire sale price of $3.2 million and contingent value rights. The La Jolla, California biotech, which has a pipeline of drugs to treat metabolic diseases, went public in June 2004 at $7 a share. Today its stock trades below 50 cents. The company burned through more than $200 million without getting any drugs to market and cut its staff down to seven people earlier this year as it ran low on cash. Under the agreement, Ligand will pay Metabasis’ shareholders $1.8 million and take over more than $1.3 million in liabilities. Metabasis shareholders will receive contingent value rights that entitle them to cash payments as frequently as every six months as cash is received by Ligand from proceeds from the sale or partnering of any of the Metabasis drug development programs, among other triggering events. Ligand has committed to spend at least $8 million in new research and development funding on the Metabasis programs within 42 months following the closing of the transaction.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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Deals of the Week: Trick or Treat!

Thursday, November 5th, 2009

Knock knock! Can a ghost biopharma get some friggin’ candy here?

Terribly sorry, didn’t mean to frighten you. We weren’t sure whether ghosts–scary or otherwise–fit into what’s acceptable Halloween attire. It’s so hard to tell these days. A helpful guide reprinted in today’s NYT from a California school:

A memo about costume appropriateness sent home recently by Riverside Drive’s principal made the following points:

¶They should not depict gangs or horror characters, or be scary.

¶Masks are allowed only during the parade.

¶Costumes may not demean any race, religion, nationality, handicapped condition or gender.

¶No fake fingernails.

¶No weapons, even fake ones.
¶Shoes must be worn.

Oh California, how you’ve come a long way since that Halloween scene in ET. Presumably anything financial-crisis, VC fundraising, or swine related is also off limits. Not to mention any member of the Congressional ‘gangs’ (sorry kids, no Chuck Grassley or Olympia Snowe costumes this year! Inexplicably still OK? Joe Lieberman). Also, Cliff Lee costumes have been banned in NY.

Here’s wishing you some fun trick-or-treating this weekend. The deals below don’t carry weapons and always wear their shoes, and win IVB’s weekly costume contest, for they are …

Sanofi-Aventis/Micromet: Sanofi is paying $12 million up-front to take a bite of Micromet’s BiTE technology platform. The two companies’ discovery deal sees Micromet going after an antigen on the surface of carcinoma cells and shepherding the discovery program through Phase I clinical development, where Sanofi takes over. Development and regulatory milestons could total $241 million for Micromet, which can earn further milestones and royalties on world wide product sales. The biotech’s platform–bi-specific T-cell engagers–recruits the body’s T-cells to recognize and kill tumor cells potently and consistently. Sanofi joins Micromet BiTE partners Bayer Schering, Merck-Serono and MedImmune.–CM

PPD/Unnamed Spinout: Contract research organization PPD announced plans Oct. 27 to split into two companies. The CRO business will remain as the parent company, and PPD’s compound partnering unit–which takes risks more typically associated with a drug development business–will spin-out into an as-yet unnamed separate public company. The new firm, to be established by mid-2010, will start with a $100 million financial stake from PPD and the portfolio of assets it already has acquired. In the meantime, it’s business as usual for the unit, PPD CEO David Grange said, and the sitll-intact company anticipates acquiring two more compounds before the end of ’09. While no CEO or head of business development has been named yet for the newco, which will employ a core group of PPD personnel. The assets that the spinout will take with it from PPD include royalty rights and sales-based milestones for Janssen-Cilag’s Priligy, a treatment for premature ejaculation that has been approved in five EU nations plus Mexico and South Korea; rights to regulatory and sales-based milestones plus royalties to Takeda’s experimental diabetes drug alogliptin; a dermatology program acquired in the purchase of Magen BioSciences this past April; and a experimental statin licensed from Ranbaxy Laboratories. Read our extended take–along with a discussion of PPD’s other announcements this week including a $100 million investment in Celtic Pharma Therapeutics–in “The Pink Sheet” Daily.–Joseph Haas

Cephalon/BioAssets Development Corp.: Though an acquisition is not definite yet, on Oct. 26 Cephalon announced that it doled out $30 million upfront for the option to buy the privately held biotech BioAssets Development Corp. The acquisition depends entirely on the outcome of BioAssets’ ongoing Phase II trial of etanercept (Enbrel) for sciatic pain, due next year. That study should help Cephalon gauge the potential for its own anti-TNF (CEP-37247) in sciatic pain, Cephalon Chief Financial Officer and Executive VP Kevin Buchi said in an interview, and buying BioAssets would give the specialty pharma the necessary IP around using anti-TNFs in that indication. Exercising the option would provide BioAssets backers with additional undisclosed cash and the potential to earn development, regulatory and sales milestone payments. –Carlene Olsen

GSK/SuperGen: GlaxoSmithKline added to its option-based alliance total this week, signing a deal with oncology specialist SuperGen to discover and develop cancer drugs based on epigenetic targets. The arrangement is GSK’s sixth option-alliance so far this year, though far from the largest in terms of upfront cash. Under the terms of the five-year deal, GSK will pay SuperGen $5 million upfront, including a $3 million common stock investment, plus up to $375 million in development and commercial milestones. SuperGen is also eligible for tiered royalties into the double-digits based on net sales of any drugs resulting from the collaboration. SuperGen says its okay with an option deal for the program, given that it is one the company already had up and running, and the investment offers a chance to keep the research moving forward. The Dublin, Calif.-based company has been studying epigenetics for a decade, since acquiring decitabine – the drug that eventually became Dacogen – in 1999. –Jessica Merrill

Medivation/Astellas: Medivation has been here before and apparently likes the terrain. In a deal similar to last year’s partnership with Pfizer on Dimebon, Medivation will receive $110 million up front to collaborate with Astellas Pharma on the development and commercialization of Phase III prostate cancer candidate MDV3100. Like the September 2008 deal in which Medivation partnered its Alzheimer’s disease candidate, the Astellas deal for MDV3100 includes significant bio bucks and gives Medivation the option to co-promote the drug in the US. Medivation could earn up $335 million in development and regulatory milestones, along with up to $320 million in commercial milestones. The companies will share US development and commercialization costs, as well as profits, equally, with Astellas responsible for full development and commercialization costs outside the US. Medivation will receive tiered double-digit royalties on ex-U.S. sales of the drug. In an investor call Oct. 27, Medivation CEO David Hung said the deal’s structure will further “our strategic goal of becoming a fully integrated U.S. specialty pharmaceutical company while retaining significant economic participation in MDV3100’s ultimate commercial success.” Medivation chose Astellas because of its global experience marketing urology drugs such as Flomax and Vesicare. ‘3100 is currently being studied in late-stage, castration-resistant prostate cancer patients who did not respond or no longer respond to therapy with docetaxel. Down the road, the two companies hope to expand the drug’s label to earlier-stage prostate cancer.—JH

http://invivoblog.blogspot.com/2009/10/deals-of-week-trick-or-treat.html

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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