Amy Ritter was Scientific Editor, BioPharm International.

Amy Ritter, PhD

On the heels of last week’s study showing that generic pharmaceuticals saved US consumers around a trillion dollars over 10 years, the Generic Pharmaceutical Association (GPhA) took the opportunity to advocate for the strategy known as pay-to-delay.  In such an arrangement, the innovator company pays to settle patent litigation in exchange for an agreed-upon market entry date for the generic. In last week’s 

, GPhA said, “While the settlement issue has engendered opposition from some who contend such generic-brand agreements are anticompetitive, the federal courts and Congress have repeatedly recognized that settlements can be desirable options in patent litigation. The record is clear: settlements allow generic drugs to come to market long before patents on the counterpart brands expire, resulting in billions of dollars in annual savings.”

		Perhaps in an effort to avoid the appearance of paying-to-delay, some innovator companies have adopted the strategy of agreeing not to launch an authorized generic in return for an agreed-upon market entry date for the nonauthorized generic. The Federal Trade Commission has taken the position that this arrangement, too, constitutes pay-to-delay. FTC filed an 

 in a private antitrust action challenging an agreement between Wyeth and Teva Pharmaceuticals, in which plaintiffs allege that Teva agreed to delay its introduction of a generic version of Wyeth’s antidepressant drug Effexor XR.  As part of the alleged no-authorized-generic (no-AG) agreement signed in 2005, Wyeth entered into an exclusivity provision in which it effectively agreed to refrain from marketing an authorized generic version of Effexor XR, and Teva agreed to delay its generic until July 1, 2010.  In the brief, the FTC says that, based on its own comprehensive study of authorized generics,  “This empirical evidence confirms what the pharmaceutical industry has long understood: that a no-AG commitment provides a convenient method for branded drug firms to pay generic patent challengers for agreeing to delay entry.”

Articles

On the heels of last week’s study showing that generic pharmaceuticals saved US consumers around a trillion dollars over 10 years, the Generic Pharmaceutical Association (GPhA) took the opportunity to advocate for the strategy known as pay-to-delay.

Different Ways of Structuring Pay-to-Delay Deals

 plans to spin off its discovery unit and Neotope Biosciences division to create an independent entity focused on R&D.  Discovery sciences will be incorporated in a new company called Neotope Biosciences that will focus on identifying and translating targets into potential therapies for chronic degenerative and other related disease areas. This entity will continue to focus on innovation, differentiated scientific advancement, intellectual property creation, and translational capability to transform science into clinical assets. 

The second company, Elan Corporation, will continue the development and commercialization of Tysabri, a monoclonal antibody therapy marketed in collaboration with Biogen Idec for multiple sclerosis and other potential indications. In addition, the company will continue to develop ELND005, a small molecule asset set to enter Phase II for a range of neuropsychiatry and symptomatic diseases that targets non-amyloid pathologies. Elan Corporation will also oversee continued interest in Janssen AI, which, with Pfizer, manages a portfolio of biologic products in early clinical development. 

"With Elan's commitment to capitalize Neotope's Bioscience, our highly talented scientific team, who have previously discovered Tsyabri and an approach to immunotherapy for Alzheimer's, will have the resources and time to advance programs for chronic degenerative diseases, such as synuclein for Parkinson's disease, along the drug development stages and provide opportunities for investors to participate in this journey," said Dr. Lars Ekman, chairman designate of Neotope Biosciences in the press release. He continued, "In the longer term, the team's heightened focus and dedication to translating unique scientific insight into clinical programs will provide benefits to the field of life sciences across a broad array of diseases for the ultimate benefit of patients.”

Elan Corporation announced plans to spin off its discovery unit and Neotope Biosciences division to create an independent entity focused on R&D.

Elan to Spin Off Discovery Sciences

Improving lives for less-that’s the tagline from the 

 from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS 

 of the savings produced by generic medicines. The study, Generic Drug Savings in the US, found an impressive $1 trillion in savings over a ten-year period (2002 through 2011). In 2011 alone, the US saved $192.8 billion by using generic medicines. This represents a 20% increase in savings over 2010, driven by patent expirations for a few significant drugs such as Zyprexa (olanzapine), Levaquin (levofloxacin), Advair Diskus (fluticasone propionate) Concerta (methylphenidate), and Lipitor (atorvastatin).

		The study looked at 2750 drugs for which there was both a branded and a generic version available on the market. Generic central nervous system and cardiovascular drugs accounted for more than half of the savings generated in 2011, and the greatest increase in savings came from oncology drugs, which generated $10 billion in savings in 2011, compared with $3 billion in 2010.

		GPhA used this data to advance support for its goals in support of unimpeded access to generics. GPhA advocates an increase in funding for FDA’s Office of Generic Drugs to ensure the timely review and approval of new generic pharmaceuticals, a fairly noncontroversial goal. It also supports continuing to allow brand and generic manufacturers to settle patent litigation out of court and bring generics to market before brand drug patent expirations. According to the conclusions outlined in the IMS report, “While the settlement issue has engendered opposition from some who contend such generic-brand agreements are anticompetitive, the federal courts and Congress have repeatedly recognized that settlements can be desirable options in patent litigation. The record is clear: settlements allow generic drugs to come to market long before patents on the counterpart brands expire, resulting in billions of dollars in annual savings.”

		Generics manufacturers Watson Pharmaceuticals and Mylan took the opportunity to preen a bit, issuing releases (

) praising the study and their own contributions to the generics market. PhRMA put the best spin possible on the results, pointing out in their own 

 that those generic savings were made possible by a steady stream of innovator products that eventually go off patent.

Improving lives for less-that’s the tagline from the press release from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS study of the savings produced by generic medicines.

Generics Help Hold the Line on Healthcare Costs

 that it is entering into agreements with Mylan Laboratories, Ranbaxy Laboratories, and Strides Arcolab to enhance access in developing countries to generic versions of its anti-HIV medicine, emtricitabine. According to the press release, emtricitabine is recommended by the World Health Organization as one of the preferred components of first- and second-line HIV therapy, but is more expensive than other available therapy options. Under the agreements, Gilead will provide technology transfer to its partners for the manufacture of emtricitabine, together with funding to assist with investment in process improvements.  The aim is to reduce overall manufacturing costs, allow Indian generics manufacturers to produce high volumes of Gilead’s antiretroviral therapy, and thereby reduce the cost of emtricitabine to be more in line with that of other therapies. 

Gilead says it has a longstanding commitment to make its antiretroviral products available at significantly reduced prices in developing countries. A key component of this commitment is nonexclusive, generic licensing agreements established with Indian manufacturers to produce and sell high-quality, low-cost versions of Gilead's HIV medicines. A total of 13 Indian companies now have licensed Gilead HIV medicines. According to John C. Martin, PhD, Gilead’s chairman and chief executive officer, “India’s pharmaceutical industry is a world leader in process chemistry, and our ongoing collaboration will be critical for furthering access to affordable, high-quality, first-line HIV treatment for developing countries.”  

Gilead Sciences announced that it is entering into agreements with Indian generic drug manufacturers to enhance access in developing countries to its anti-HIV medicine, emtricitabine.

Gilead Partners with Indian Manufacturers on HIV Medicines

The US District Court for the District of Columbia has 

 that FDA has the authority to regulate stem-cell treatments as drugs. At issue was an FDA enforcement action against Colorado-based Regenerative Services, a clinic that offered treatments in which cells from patients’ blood and bone marrow were removed, processed to isolate and expand the stem cell component, then reinfused to treat joint and muscle pain. Regenerative Services claimed that it was practicing medicine as allowed by Colorado law, and therefore exempt from FDA oversight. FDA does not consider minimally processed tissue products, such as skin used for grafts or platelets used for transfusions, to be drugs. However, the court agreed that the stem-cell product was more than minimally processed tissue, and therefore its use constituted the manufacturing, holding for sale, and distribution of an unapproved biological drug product. As such, the product required the submission of a biologic license agreement and manufacture under cGMP.

		The ruling paves the way for FDA to enforce oversight over the numerous stem-cell clinics that have come into existence over the past few years. Such clinics offer autologous stem-cell treatments for any number of ailments, including arthritis, cancer, wound-healing, and neurodegenerative disorders. None of the treatments are backed by clinical trials, and the products are of unknown purity and potency. The proliferation of such treatments prompted FDA to issue a consumer 

, advising prospective patients that “FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.”

		There’s some grumbling on the blogosphere about FDA being able to regulate what patients are able to do with their own tissues (see Regenerative Services’ 

 to the ruling). Others are concerned that overzealous enforcement will stifle the development of new treatments (see this 

 from Forbes). But these treatments are being promoted to cure, prevent, and mitigate disease-that sure sounds like a drug to me.

The US District Court for the District of Columbia has ruled that FDA has the authority to regulate stem-cell treatments as drugs.

FDA Asserts Authority Over Stem-Cell Treatments

Merck Serono, a division of Merck KGaA, announced in June, 2012 that it would be closing down operations in Geneva, Switzerland as part of its 

 activities, but providing up to EUR 30 million ($36.9 million) in funding for start-up companies to reemploy some of those displaced workers. The first such start-up was 

 on Jul. 30, 2012, funded by EUR 2.1 million ($2.57 million) in seed money from Merck Serono’s Entrepreneur Partnership Program.

The new company, Prexton Therapeutics, will employ Merck Serono scientists to continue work around Merck Serono’s R&D portfolio in the field of Parkinson’s disease. Its programs will leverage Merck Serono’s portfolio of compounds targeting the metabotropic glutamate receptors mGluR3 and mGluR4. Prexton Therapeutics plans to develop the mGluR programs from lead optimization up to clinical Phase I and will look for partnership and licensing opportunities for further development.

According to François Naef, chairman of the board of directors of Merck Serono, “We are really proud and satisfied that this first project is now coming to life. Through such initiatives, not only will we be able to maintain jobs in the Geneva area but also unique expertise.” 

Merck Serono will be closing down operations in Geneva as part of its restructuring activities, which includes a spin off of the its Parkinson's disease R&D portfolio to a new company named Prexton Therapeutics.