Mylan expects to secure patent protection for the hypertension drug nebivolol until 2015, six years after the composition of matter patent expires, President and Chief Operating Officer Richard Moldin told analysts.

"There are additional patents that are pending" on nebivolol that "have been issued in all countries other than the U.S.," the exec said April 6. "We feel very confident that those patents will be issued."

Uncertainty about the length of nebivolol's patent life was one reason the license owner, Janssen, decided not to pursue development, Moldin said. Mylan obtained the U.S./Canadian rights to nebivolol on April 5.

"It was not really known two years ago if this patent extension was going to be possible to 2015," Moldin said. "It created an aura of uncertainty within the Janssen organization as well as to other people they tried to license it to." Janssen's lack of experience in the cardiovascular market was another reason the company did not bring nebivolol to market, he said.

Mylan recognizes it may need a partner to launch nebivolol. "I don't think we would box ourselves into a position of not seeking a co-development or co-marketing partner from someone who could bring some expertise to the table," the exec said. "When you're into marketing products, particularly in the cardiovascular area, you're up against some pretty large sales forces."

While Mylan has had some "extremely positive" discussions, finding a partner is not required for launch. "If we can't find someone with the right terms, we are capable of doing it on our own," the exec said.

Mylan expects to file an NDA for nebivolol for hypertension by late 2003. Depending on the outcome of the patent filings, the firm will consider pursuing an indication for congestive heart failure. Mylan will spend $30 mil. in R&D for a hypertension indication, and an additional $40 mil. on CHF.

Nebivolol generates $50 mil. in annual sales in Europe as Nebilet. Revenues in the U.S. could reach $150 mil.-$200 mil. by 2008-2009, Mylan says.

Nebivolol appears to have a dual mechanism of action that combines selective beta 1 receptor blockade with nitric oxide-dependent vasodilatation unique from other beta blockers, Mylan said.

Five Phase III trials are set to start this spring, one of which will compare nebivolol to other beta blockers in African-Americans. Another trial will study tolerance to see if nebivolol causes less fatigue than other beta blockers.

On the generic side, Mylan expects to launch versions of metformin (Bristol-Myers Squibb's Glucophage) in the second or third quarter of FY 2002 and isotretinoin (Roche's Accutane) in the fourth quarter.

Mylan anticipates limited generic competition for isotretinoin due to the drug's toxicity and required patient registry. Roche has been attempting to extend exclusivity through additional formulas; a once-daily dose is "approvable" at FDA.

Mylan is also monitoring Bristol's exclusivity strategy for Glucophage. "We all know what [Bristol] has done with buspirone....There's still an uncertainly as to how and what will happen with this product once an approval is reached, so...until somebody launches it, it is very difficult to put [forth] any sort of projections."

Bristol is using an evergreening strategy to switch patients from Glucophage to the second-generation diabetes drugs Glucovance and Glucophage XR (¹ Also see "Bristol Glucophage XR Gets 35% Of New Rxs From Metformin Switches" - Pink Sheet, 29 January, 2001.).

Buspirone and paclitaxel are expected to drive generic sales in FY 2002. Mylan will launch generic Taxol in the second quarter. The company launched a 15 mg dose of generic BuSpar March 29, one day after receiving approval (² Also see "Par 7.5 Mg Buspirone Aims To Capture Portion of 15 Mg Split-Tablet Market" - Pink Sheet, 2 April, 2001.).

Regarding acquisitions, Moldin said Mylan "continues to look" at potential business combinations. "Sometimes they make sense, sometimes they don't."

"If you ask Watson today, would they like to have a chance and go back and retroactively make the Schein decision, they might give another decision then they previously gave. We had a chance to look at that, we just didn't think it was going to work for us." Shortly after closing the Schein deal Aug. 28, Watson preannounced an earnings shortfall due to lower-than-expected Schein product sales.

Mylan Nebivolol Hypertension Drug Patent Protection Expected Through 2015

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