USFDA grants tentative approval to MDRNA's generic calcitonin-salmon nasal spray

The USFDA has granted tentative approval to MDRNA's ANDA for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex's 180-day exclusivity period, or June 2009.

MDRNA's generic calcitonin-salmon nasal spray is the generic equivalent of Miacalcin marketed by Novartis Pharmaceuticals Corporation. US sales of Miacalcin were approximately $147 million in 2007. On December 23, 2003, FDA accepted for filing MDRNA's 505(j) paragraph 4 ANDA for the product. In October 2004, MDRNA and Par Pharmaceutical Companies, Inc. entered into an exclusive license and supply agreement for US distribution and marketing of the product. Under terms of the agreement, MDRNA is responsible for obtaining regulatory approval and manufacturing, and will receive product transfer payments for manufactured product and profit sharing following commercialization.

Lupin settles desloratadine lawsuit with Schering-Plough

Lupin Ltd has announced that the company has settled all ongoing Hatch-Waxman litigation relating to desloratadine tablets, the generic version of Schering-Plough's 'Clarinex' tablets. As per the terms of the settlement, Lupin will be licensed under the relevant desloratadine patents, and free to commercially launch its generic desloratadine product, on July 1, 2012, or earlier in certain circumstances.

Lupin had earlier filed a Paragraph IV certification to, among others, US Patent Nos. 6,100,274, 7,214,683 and 7,214,684, contesting that these patents were either invalid or had not been infringed upon - resulting in the subsequent litigation by Schering Corp. and Sepracor. Schering-Plough's Clarinex tablets had US sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.

Warner paragraph IV certification for DORYX

Warner Chilcott's subsidiaries and Hospira have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. and Mylan Pharmaceuticals Inc. ("Mylan") advising that each such company has filed an ANDA for generic versions of DORYX 100 and 75 mg delayed-release tablets. DORYX is a tetracycline-class oral antibiotic protected by Mayne's Patent No. 6,958,161 (the "161 Patent") which expires in 2022. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008.

Aurobindo receives tentative approval for Perindopril erbumine and Ecitalopram Oxalate

Aurobindo's perindopril erbumine tablets 2mg, 4mg, 8mg and escitalopram oxalate oral solution 5mg (base)/ 5ml have been given tentative approvals by USFDA. Perindopril erbumine tablets are generic of Solvay Pharmaceuticals Aceon tablets and Escitalopram oxalate oral solution are the generic of Forest Laboratories' Lexapro oral solution. Aurobindo now has 85 approved ANDAs from the US FDA (61 final approvals, 24 tentative approvals).

Competition in Pharmaceutical Sector-European Commission preliminary report

Last Friday, the European Commission published a 426-page preliminary report (http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf) regarding its competition inquiry into the European pharmaceutical sector. The Commission commenced the sector inquiry last January to examine why fewer new medicines were being brought to market in Europe and why generic entry seemed to be delayed in some cases (the report notes that while 40 new medicines were introduced annually between 1995 and 1999, only 27 were introduced annually between 2000 and 2007). The Commission has created dedicated webpage (http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/index.html) providing additional information regarding the sector inquiry into pharmaceuticals competition.

The Commission has offered its initial finding that "there is evidence that originator companies have engaged in practices with the objective of delaying or blocking market entry of competing medicines" and that as a result, "competition in this industry does not work as well as it should." The Commission reached this conclusion by examining a sample of 219 medicines facing a loss of exclusivity between 2000 and 2007, determining that but for delaying and blocking strategies employed by originator companies (i.e., innovator or brand companies that develop and sell new medicines), European consumers would have saved an additional € 3 billion ($3.79 billion) over this period.

The Commission concluded that the originators' strategies resulted in a delay of generic market entry of between four and seven months. In conducting the sector inquiry, the Commission sent out requests for information to 43 originator companies and 27 generic companies, engaged in a dialogue with industry associations at the European level, and consulted with representatives of consumer and patients associations, insurance companies, doctors, pharmacies, wholesalers, hospitals, parallel traders, patent offices, and competition authorities. Interestingly, the report states that the two biggest stakeholders -- the originator and generic companies -- were in agreement regarding the need to create a single Community Patent and a unified and specialized patent judiciary in Europe. Stakeholders and members of the public have until January 31, 2009 to submit comments concerning the Commission's preliminary findings, with the Commission expected to issue a final report sometime in the spring of 2009.