Deals of the Week Is On Deadline

Even as summertime drags its lazy weight across the Northern Hemisphere, some among us are feeling the intensity of impending deadlines. Okay, the NFL owners and players' union beat the clock and are on track for an opening night kickoff. But the lack of adult behavior inside the Washington beltway means the Prez and Congress have just four days to decide whether to risk a plunge into another nationwide recession. And though the San Francisco Giants may have welcomed their newest team member (pictured above, though still channeling his 2009 season per his vintage Web site), other teams are still scrambling to move high-value players in exchange for prospects (or vice versa, depending on pennant chances).

Even Deals of the Week itself is feeling the pinch on this summer Friday afternoon.

Not everyone is under the same time pressures, however. If Valeant Pharmaceuticals really has made an approach to buy out Sweden's Meda AB, things appear to be moving along at a snail's pace. The Wall Street Journal reported Wednesday that Valeant, a Canadian specialty pharma with a robust appetite for acquisitions, has made Meda an offer that could range above $4 billion, sometime in the last two weeks.

Meda, for its part, swiftly refuted the Journal's story without explicitly denying that a deal could be in progress, saying only that Meda "has not received an approach of the kind that is described in the article." Maybe they're just waiting for someone to get back from vacation and check his voice mail. It's the slow season, after all.

If the parties are indeed moving toward a deal, however slowly, it wouldn't be out of character for either. The two have joint ventures in Canada, Mexico, and Australia, and Meda has already licensed a couple of drugs to Valeant, taking $76 million up-front for dermatitis cream Elidel (pimecrolimus) and cold sore treatment Xerese (acyclovir/hydrocortisone) in a June partnership. Meanwhile, Valeant has already shown a willingness to spend big this year. It attempted but ultimately failed to buy Cephalon for $5.7 billion this spring, but instead settled for a spree of other acquisitions, among them dermatology units Dermik and Ortho Dermatologics, Lithuanian specialty pharma Sanitas, and generics seller PharmaSwiss.

The Journal story suggests that Meda is open to a sale, but is willing to take its time in finding the right buyer. Some of us, however, don't have that luxury (damn editors). The clock's ticking and time's a-wasting, so let's move it along to...

Ironwood/Depomed: Still enjoying the fruits of its 2010 IPO, Ironwood Pharmaceuticals is trying to expand its pipeline beyond its lead program linaclotide, a Phase III constipation and irritable bowel syndrome drug developed with Forest Laboratories that would be its first marketed product. The biotech inked a deal with Menlo Park, Ca-based Depomed on July 27 that will allow Ironwood rights to Depomed’s AcuForm gastric retentive drug delivery technology, which it intends to use with one of its early-stage development programs. The company did not disclose to which program the technology would be applied. The technology works to deliver targeted, extended release drugs directly to the upper GI tract at the desired rate. AcuForm technology is already approved with the use of two other drugs: Santarus’ diabetes drug Glumetza and Abbott Laboratories’ post-herpetic neuralgia drug Gralise. Depomed will receive an undisclosed upfront fee, as well as milestone and royalty payments on any products that result from the collaboration. Ironwood, which raised $188 million in its February 2010 public offering, will handle development and commercialization of the product, but Depomed will help with initial product formulation. – Lisa LaMotta

Trius/Bayer: Trius Therapeutics said Wednesday, July 27, Bayer Pharma has licensed regional commercial rights for the Phase III antibiotic torezolid. For an upfront fee of $25 million, Bayer receives rights to all countries in Africa, Latin America, the Middle East and Asia, except for North and South Korea, where rights are held by Dong-A Pharmaceuticals. Bayer will pay 25% of development costs toward global approval in skin infection and pneumonia, up to $69 million in milestones and double-digit sales royalties. Trius retains all rights in the US, Canada and Europe. Torezolid is one of several antibiotics being developed to treat emerging drug-resistant bacteria such as Methicillin-resistant Staphylococcus aureus (MRSA). Many clinicians say the efforts are not sufficient to head off widespread infection from the new organisms, prompting new efforts to spur development and ease regulatory burden. The deal comes as Trius pushes torezolid toward the regulatory finish line after the FDA spent years rewriting its guidance on antibiotic approval criteria. When FDA issued its new guidance for acute bacterial skin and skin structure infection (aBSSSI) in early 2010, the firm stepped back to revise its Phase III trial and a few months later agreed with the agency on a Special Protocol Assessment. Trius, which soon will begin pivotal trials of an intravenous version of torezolid, hopes to have top-line data for the Phase III study of the orally dosed version early next year. -- Alex Lash

Merck/Astellas - Merck is acquiring North American rights to intravenous vernakalant from Astellas Pharma’s U.S. subsidiary, Merck announced on July 26. The agreement will consolidate its interest in the cardiovascular drug to include worldwide rights to both the IV and oral formulations. Until now, Merck’s ownership included global rights to the oral drug and ex-North American rights to the IV formulation, which is already approved and marketed in the EU, Iceland and Norway under the brand name Brinavess as a treatment for acute atrial fibrillation. Financial terms were not disclosed but Merck will pay Astellas an upfront fee along with potential development, regulatory and sales milestones. As part of the agreement, Merck assumes the responsibilities Astellas undertook in 2003, when the Japanese pharma licensed the IV formulation from the drug’s discoverer, Cardiome Pharma. Cardiome will continue to bear 25% of development costs, while Merck will be responsible for 75% of development costs and all manufacturing and marketing costs. Merck had acquired ex-North American rights to IV vernakalant from Cardiome in 2009, along with worldwide rights to an oral formulation currently in Phase II for prevention of chronic AF and maintenance of normal heart rhythm. For its efforts, Cardiome received $60 million upfront, along with the potential for up to $540 million in milestones and tiered royalties on product sales.—Joseph Haas

Fujifilm/Dr. Reddy's: In its latest step intended to transform itself into a medical and life sciences company, Japan's Fujifilm has partnered with Indian generic drug maker Dr. Reddy's Laboratories for a joint venture that will bring generics to the Japanese market. Ownership of the JV will be split 51%-49% in favor of Fujifilm. The photo supply maker says it will draw upon its own advanced quality control techniques while incorporating Hyderabad-based Dr. Reddy's pharma expertise as a manufacturer and global supplier. Generics account for nearly a quarter of Japanese drug sales by volume, according to Fujifilm; the companies hope to target the country's aging population with generics that fit the overall marketplace. The joint venture is aiming to launch its first products within three to four years. Fujifilm has expanded beyond film in recent years, and now manufactures materials for flat panel displays, graphic systems and optical devices as well as the life sciences industry. - Paul Bonanos

Image of the awesome Carlos Beltran courtesy of Flickr user Keith Allison, reproduced under Creative Commons license.