Advanced Life Sciences

Wyeth, ALS ink marketing deal

Maureen Martino — Wed, 01 Oct 2008 11:30:40 -0400

Advanced Life Sciences has signed a development marketing pact with Wyeth for cethromycin, an antibiotic for community respiratory tract infections, in a deal that could be worth $100 million. ALS also announced today that cethromycin has been submitted to the FDA for approval.

As part of the deal, Wyeth gains the right to the antibiotic in the Asia Pacific region, excluding Japan. Wyeth made an up-front equity investment in Advanced Life Sciences through the purchase of 4.9 percent of ALS's stock. In addition to future royalty payments, ALS will gain milestone and regulatory payments based on successful achievement of clinical, regulatory and commercial objectives. The two companies will work together on additional clinical data in Asia to support further regulatory filings there. ALS retains rights to the drug in the rest of the world, excluding Japan, where Abbott has rights to cethromycin.

- see the release
- read the article from TheStreet

C&L: Wells named Biovail CEO

Wed, 23 Apr 2008 06:59:52 -0400

Biovail has named William Wells, Loblaw Cos. Ltd.'s chief financial officer, as its new chief executive, replacing Douglas Squires, who will become Biovail's chairman.

ARUP Laboratories co-founder Carl R. Kjeldsberg, MD, will retire as chief executive officer at the end of June 2009.

Bioniche Life Sciences announced late last week that its chairman, Hy Isenbaum, has died.

DUSA Pharmaceuticals announced that the role of D. Geoffrey Shulman, MD, chairman of the board and chief strategic officer, is expected to change as a result of a serious health condition.

US Oncology's CFO Rick McCook is resigning to explore opportunities in a retail or manufacturing business.

MannKind Corporation announced that Matthew J. Pfeffer will join the company as corporate vice president and CFO, effective April 21.

Gilead Sciences announced that Robin L. Washington will join the company in May 2008 as senior vice president and chief financial officer.

Medicago announced the return of Pierre Labbé as chief financial officer on a full-time basis.

Advanced Life Sciences Holdings says that R. Richard Wieland II, executive vice president and chief financial officer, has resigned to pursue other opportunities.

BioReliance Corporation has named John Ludwig Kolman, PhD, senior director, research and development.

Eisai has named Robert Laverty to the newly created position of vice president of U.S. communications.

Speedel has named Dr. Harald Schafer the new head of corporate communications and investor relations.

Encorium Group announced the resignation of Lawrence R. Hoffman, the company's chief financial officer, effective May 2.

ProGenTech has made several executive management appointments. They are: Dr. Paul Richardson, vice president for R&D; Dr. Jesus Ching, chief scientist; Sarah Wenning, VP of U.S. operations; Dylan Bird, director of business development; David Hu, VP of engineering.

Zogenix has named Cynthia "Candy" Robinson as chief development officer and Mark Thompson as vice president, sales and managed markets.

Addex Pharmaceuticals has named Laurent Massuyeau as head of business development.

Spherix named Randy Brown as chief of operations.

Ovation Pharmaceuticals has named Samuel Yonren, M.D. as vice president, patient safety with responsibility for global drug safety for all Ovation products.

Migenix has appointed Pieter Dorsman to its board of directors.

VIVUS has named Charles J. Casamento to the board of directors.

Resolvyx Pharmaceuticals has named Timothy J. Barberich and George M. Milne, Jr., Ph.D, to the board of directors.

Avexa Ltd has named Nathan Drona a non-executive director of the company.

Introgen Therapeutics has appointed Robert "Bob" Pearson to its board of directors.

Edwards Lifesciences announced that Vernon R. Loucks Jr. is retiring from the company's board of directors.

Oncolin Therapeutics has added Sandra Silberman, M.D., Ph.D. to its Scientific Advisory Board.

ALS sees strong data in Phase III antibiotic trial

Thu, 15 Nov 2007 06:59:54 -0500

Advanced Life Sciences is touting data from a recent trial of its antibiotic cethromycin. The therapy produced positive data that it can fight pneumonuia effectively and safely and demonstrated an ability to combat the MRSA superbug as well. ALS officials told the Chicago Tribune that the data was good enough to pursue FDA approval. In the trial, cethromycin essentially matched the efficacy of a standard of care in fighting community-acquired pneumonia. Flavin added that the company planned an NDA next year with marketing to commence in 2009.

"We are very excited to have met all of our endpoints in Trial CL-05, and we are pleased to have successfully completed the clinical development program of cethromycin. The results attained in this trial, along with the positive results achieved in Trial CL-06 reported in June of this year, will form the core of our New Drug Application submission and positions us well with prospective commercial partners," said Dr. Michael Flavin, chairman and CEO of Advanced Life Sciences.

- see the release for more
- here's the report from the Chicago Tribune

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ALSO NOTED: Pharmaxis touts late-stage study; ALS gains orphan drug status; H5N1 passed human-to-human; and much more...

Wed, 29 Aug 2007 06:59:50 -0400

> Pharmaxis says that a late-stage study of its experimental drug for a chronic lung condition demonstrated its effectiveness. Release

> Advanced Life Sciences says the FDA has granted orphan drug status to its cancer drug, ALS-357. Report

> Simmering fears of a bird flu pandemic have been heating up in the wake of a new study that confirms human-to-human spread of the deadly disease. Experts at Fred Hutchinson Cancer Research Center confirm that the avian influenza A (H5N1) virus in 2006 spread between a small number of people within a family in Indonesia. A number of biotech companies have joined the race to develop a vaccine against bird flu. Report

> Families of Spinal Muscular Atrophy and Tikvah Therapeutics announced a collaboration to accelerate the clinical development of TIK-201 for the treatment of spinal muscular atrophy. Release

> Tercica says it expects the FDA to make a decision on Somatuline Autogel later in the week. Report

> The FDA has accepted Merck's NDA for Cordaptive. Report

> Roche has lost turf to Amgen in their patent battle over Mircera, an anti-anemia drug now under FDA review. FiercePharma

> In another step under the patent shelter for AstraZeneca's Seroquel, the company won approval from Dutch regulators for an extended release form of the drug. FiercePharma

And Finally…The battle of the bulge is not going well for the forces of slim. A new study shows that obesity grew worse in 31 states last year, with no state posting an advance. Report