The agreement is part of Pfizer’s Established Products Business Unit strategy that the pharma giant launched in 2008 in an effort to create smaller, more accountable business units. The Unit focuses on the commercialization of products whose market exclusivity has been lost; it currently rakes in $10 billion annually in global sales.

Pfizer also entered into a five-year agreement with Bausch & Lomb to co-promote the companies’ branded ophthalmic products.

Under the terms of the agreement, Pfizer’s Xalatan (latanoprost ophthalmic solution) and Bausch & Lomb’s Alrex (loteprednol etabonate ophthalmic suspension 0.2 percent), Lotemax (loteprednol etabonate ophthalmic suspension 0.5 percent), and Zylet (loteprednol etabonate 0.5 percent and tobramycin 0.3 percent ophthalmic suspension) will be promoted by both company’s sales forces. Bausch & Lomb’s besifloxacin, which is currently under review for FDA approval, was also included in the deal.

Elan cut 14 percent of its global work force last Wednesday as a part of an ongoing strategic review process. The company announced that it would postpone biologics manufacturing, redesign R&D in its biopharmaceutical business, and reduce related G&A and support activities. As a result, 230 positions were hacked. Elan said half the positions cut would be in Ireland, while the other half would be in the United States. They expect the changes to reduce 2009 operating costs by $30 million to $35 million.

Seattle-based Trubion Pharmaceuticals announced last Wednesday that it will reduce its workforce by 25 percent to 25 employees. Citing capital market and global economic uncertainty, Trubion says it is proactively cutting costs and investing in its strongest near-term opportunities to ensure long term success. Trubion develops protein therapeutic products for autoimmune and inflammatory diseases and cancer.

Watertown, MA-based Panacos Pharmaceuticals announced last Monday that it will reduce its work force from 11 to just four employees, close its Gaithersburg, MD, facility, and consider selling the company or its HIV development programs in an attempt to preserve financial resources. The company also announced it will de-list its common stock from trading on NASDAQ. According to a press release, if Panacos is unable to enter into a transaction or agreement, the company may be forced to shut down come second quarter. Panacos specializes in developing small molecule oral drugs for HIV and other viruses.

Thus far in 2009, Merck has handed out 750 pink slips to US sales reps as a part of a global restructuring plan announced last October. The plan was designed to reduce Merck’s work force by 12 percent—about 7,200 positions worldwide—by 2011, and save $3.8 billion to $4.2 billion by 2013. Although many US sales reps were notified of their dismissal earlier this year, some got word last Monday. When all is said and done, Merck expects its US sales force to be slimmed by 12 percent to 5,600.

The CVT board rejected Astellas’s second proposal last Friday stating that the Astellas proposal undervalued the company and is not in the best interest of the shareholders.

In a press release issued this morning Astellas stated, “While we continue to prefer to reach a negotiated agreement with CV Therapeutics’ Board, their refusal to engage with us regarding our proposal has left us with no alternative but to take our offer directly to CV Therapeutics’ stockholders. We believe our offer provides CV Therapeutics’ stockholders with immediate cash value that exceeds what the company could reasonably expect to deliver on it own, particularly given current uncertain market conditions and execution risks inherent in CV Therapeutics’ standalone strategy.”

The tender offer is a 41 percent premium to CVT’s closing share price of January 26, 2009, and a 69 percent premium to CVT’s 60-day average closing price ending on January 26th.

The bidding war began in November when Astellas made the first move to buy CVT. When the offer wasn’t accepted, Astellas made a second proposal to the board in late January, which was once again rejected by CVT on February 20th.

Meanwhile, Astellas US Holding, Inc., a subsidiary of Astellas Pharma Inc., today announced that it has filed a lawsuit in the Delaware Chancery Court against CV Therapeutics Inc. According to the press release its directors are seeking, “declaratory and injunctive relief to prevent CV Therapeutics from applying its recently amended stockholders rights plan in a way that would prevent CV Therapeutics’ stockholders from tendering their shares into the tender offer announced by Astellas today and preclude CV Therapeutics from claiming that a 2000 agreement between Astellas and CV Therapeutics has been violated by the Astellas tender offer.”

Acorda filed a New Drug Application for fampridine on January 30, and FDA approval is expected in about 10 months. If green-lighted, fampridine will be the first drug approved with the indication to improve walking ability in people with MS, and Acorda’s second commercialized product. It currently markets Zanaflex (tizanidine) for the management of spasticity.

This is the second round of late-stage clinical trials for fampridine. In 2004, the drug completed Phase III trials for reducing spasticity in patients with spinal cord injuries, but the studies did not achieve statistical significance in their primary endpoints.

New data from the recent randomized, double-blind, placebo-controlled trial showed an average 25 percent increase in walking speed for MS patients treated with fampridine, compared to a 5 percent increase in the placebo group.

“We focused particularly on walking because walking is by far, along with general energy loss and fatigability, the most pervasive, common, and the most dreaded part of MS,” said Acorda CEO Ron Cohen, MD. “You can probably live with one hand being weak if the other hand’s OK, but if you can’t walk you’re stuck—you’re utterly dependent.”

MS is a progressive condition where the immune system attacks the nervous system, destroying myelin and interrupting communication signals between the brain and the spinal cord. Nervous system damage may cause muscle weakness, imbalance, and loss of coordination, which can eventually lead to decreased mobility or paralysis.

According to the National Multiple Sclerosis Society, about 400,000 Americans and 2.5 million people worldwide are diagnosed with MS. Between 64 and 85 percent of those patients have trouble walking.

Used in tandem with first-line medications, fampridine works by blocking the open potassium channels exposed after demyelination, which interrupts message transmission between axons. By sealing the leaks, fampridine allows impulses to flow with reduced interference and restores mobility.

In the early days of MS treatment development (mid-90s) the options were few. As Cohen put it, “It was diagnose and adios.” But with the biotech revolution came giant leaps towards effective MS disease management, and the first line treatments—Avonex (interferon beta-1a), Copaxone (glatiramer acetate), Tysabri (natalizumab)—were born. Now the next generation of therapy is using the platform built by these veteran drugs as a stage to showcase their new, more targeted approaches. Instead of attempting to slow its progression like older treatments, new drugs take aim at the disease and the debilitating symptoms and side effects that come along with it.

The latest Phase III data translates clinical trial numbers into tangible results for patients. Already, Acorda has solicited the responses of study participants to a 12-Item survey meant to measure fampridine’s perceived impact on mobility improvement.

“We showed that this average 25 percent improvement in walking speed on this test correlates very strongly with improvements in any number of activities in daily life that are related to walking,” said Cohen. “It was the first time that anyone had ever shown that a drug could improve neurological function and real functionality in people with MS.”

Before his speech, Witty told the Wall Street Journal that the cuts won’t affect GSK very much, noting that 20 percent of its profits in the poorest countries would total between GBP 1 million and GBP 2 million per year. According to the Journal, GSK’s hepatitis B, genital herpes, malaria and asthma meds will be among those hit with a price cut.

In the February issue, Pharm Exec tackled the complex issue of access, and highlighted some of the new models pharma is using to bridge the gap between wealth and health. For the story, Executive Editor Joanna Breitstein spoke with Kate Taylor, vice president of global vaccine policy at GlaxoSmithKline Biologicals, about the challenges global access poses for the pharma industry.

Click here for an edited version of the interview transcript.

The Healthcare Businesswomen’s Association (HBA) today announced that Dr. Deborah Dunsire, president and CEO of Millennium: The Takeda Oncology Company, will be honored as the 2009 Woman of the Year.

Dunsire, a 20-year veteran of biologics and pharmaceutical business, was named president and CEO of Millennium in July 2005. She has received numerous awards for her achievements in the fields of oncology, hematology, and inflammatory diseases, including an honorary Doctor of Science from Worcester Polytechnic Institute, the American Cancer Society’s Excalibur Award, the Creative Spirit Award from the Creative Center for Women with Cancer, the New Jersey Women’s Fund Achievement Award, and the Gilda’s Club NYC Corporate Honor.

“Leaders like Dr. Dunsire continue to serve as role models for all women entering the healthcare industry, and set new standards for accomplishment,” said Ceci Zak, HBA president. “The advancements that she has helped pioneer in oncology have made an overwhelming impact in the field, and are an inspiration to us as healthcare executives.”

At the 20th annual HBA Woman of the Year luncheon in May, Dunsire will be recognized for her contributions to the healthcare industry along with a group of “Rising Stars,” and winners of the Honorable Mentor and Star Volunteer awards.

Stay tuned to Pharm Exec for more HBA Woman of the Year coverage, including a feature about Dr. Dunsire in our April issue and a special podcast series where we’ll chat with previous winners of HBA’s Woman of the Year in honor of the award’s 20th anniversary.

Emmens, a 35-year pharma industry veteran, has been a Vertex director since 2004. He previously served as CEO of Shire plc and Astra Merck Inc., and as president for Merck KGaA’s global prescription pharmaceuticals.

As Shire CEO, he expanded the company through mergers and acquisitions such as Transkaryotic Therapies Inc. in 2005, and New River Pharmaceuticals Inc. in 2007, diversifying the company’s product portfolio and quadrupling its share price.

With a potential blockbuster in the pipeline—protease inhibitor telaprevir, currently in phase III clinical trials—Emmens will have another chance to flex his management and marketing muscles. Last November, phase II trial results showed a 52 percent SVR12 in Hepatitis C Virus (HCV) treatment-failure patients with a 24-week treatment duration, therefore reaping better results in half the time than the existing standard.

“We have a rare opportunity to create a world-class commercial enterprise that complements Vertex’s excellence in R&D innovation,” said Emmens in a Vertex press release. “In the area of hepatitis C, and also in cystic fibrosis, Vertex has the potential to transform patients’ lives and build tremendous value. Together with the employees my goal is to make this vision a reality.”

Daschle seemed like a shoe in for the HHS position from the start because of his close congressional ties and well-chiseled plan for getting the job done. He was also asked to oversee a new White House Office of Health Reform.

But with the recession getting deeper and a vacant HHS top spot, the outlook for change in 2009 is starting to look grim. According to a report released today by analysts at Miller Tabak, Daschle’s withdrawal “effectively terminates any chance of healthcare reform in 2009.”

“Given the time it will take to choose and vet a new HHS secretary it appears not likely that person will be able to impose meaningful change in the near-term,” the report said. “If we are correct in this view, to fix healthcare, the administration will have to pick a leader with strong congressional ties and a great deal of moral authority who knows healthcare in order to spearhead reform.”

The names floating around as replacements include former Gov. Howard Dean of Vermont, Govs. Kathleen Sebelius of Kansas, Edward Rendell of Pennsylvania, Jennifer Granholm of Michigan, and John Kitzhaber of Oregon, according to the New York Times. Governors are being considered because of their experience with running state Medicaid programs.

Without a strong-headed health reform leader in the executive branch—as Daschle was thought to be—the responsibility to produce change may fall on Congress’ shoulders. Senator Max Baucus of Montana, chairman of the Finance Committee, and Senator Ted Kennedy of Massachusetts, have been working on health reform plans since last November and plan to propose a bill later this year.

Although a congressional bill is likely to be introduced, analysts at Miller Tabak expect push-back from the executive branch: “Although it appeared that the administration was willing to let the congress lead a healthcare reform effort, in contrast to the Clinton effort, given the wrangling over the recent stimulus package the administration will most likely want more of a say in future large-scale legislation.”