In Brief

Novartis ships Excedrin Migraine; Perrigo will launch mini nicotine lozenges; Matrixx ups offer to buy ProPhase; Merck consolidates HQ in Summit, N.J.; NBTY expects at least 3% sales boost; FDA will hold risk communication meeting; more news In Brief.

Novartis ships Excedrin Migraine

Novartis AG begins shipping Excedrin Migraine Oct. 15, and the product will be available later this month as the firm continues ramping up manufacturing of OTC product lines at its Lincoln, Neb., facility. The firm Oct. 10 said Excedrin Extra Strength will ship to stores in January 2013, but did not estimate the return of other products unavailable since the Lincoln plant shutdown.

Novartis Consumer Health Inc. originally planned to resume production in Lincoln in May after suspending shipments from the site in December 2011 when FDA officials found the plant did not investigate consumer complaints of chipped or broken pieces in Excedrin, Bufferin, Gas-X Prevention and NoDoz products (Also see "LIPIL for Moms" - Pink Sheet, 25 Oct, 2004.). “We are bringing on a stream of contract manufacturers for these brands,” Novartis CEO Joseph Jimenez said during the firm’s July 19 second-quarter earnings call. “So it is going to be a slow build. It's going to be slower than what we expected, because it took longer to get the thing up and to start to build inventory.”

Perrigo will launch mini nicotine lozenges

Perrigo Co. PLC will begin shipping mini nicotine lozenges to retailers in the next 90 days, following FDA’s approval of its abbreviated new drug application for 2-and 4-mg mint lozenges. The firm said in an Oct. 10 release the ANDA approval is the first for a store brand product comparable to GlaxoSmithKline PLC’s Nicorette Mini Lozenge, which sells an estimated $30 million at retail. Perrigo also makes smoking-cessation gums and regular lozenges.

Matrixx ups ProPhase offer

[Matrixx Initiatives Inc.] ups its initial offer to buy ProPhase Labs Inc. by 14.3% to $1.60 a share after ProPhase declined an initial offer of $1.40. Matrixx, maker of Zicam zinc cold remedies, first made a non-binding proposal May 29 for $1.40 per share in cash, and after a rejection, resubmitted the same offer Sept. 6. Matrixx filed a voluntary presentation with the Securities and Exchange Commission Oct. 9 in connection with its revised offer. The presentation stated ProPhase, which makes Cold-EEZE brand zinc products, spent more than 80% of net sales on operating expenses and has reported $12.9 million in cumulative losses from operations since 2009.

"Our offer is especially attractive when considering that we believe ProPhase faces significant challenges by remaining as a standalone entity, including lack of scale, an unsustainable financial model and limited liquidity," Matrixx CEO Marylou Arnett said in an Oct. 9 release. If the acquisition succeeds, it will merge the two largest market players in the zinc cold remedy market (Also see "Matrixx Rejected On ProPhase Labs Bid, Picks Up Option On Shares" - Pink Sheet, 24 Sep, 2012.).

Merck consolidates HQ

Merck & Co. Inc. will shift its global headquarters from Whitehouse Station, N.J., to Summit, N.J., where consumer care and several other Merck business units are. The move slated for 2014 is the latest stage of Merck’s integration with Schering-Plough Corp., the firm said Oct. 9. The relocation away from Whitehouse Station, where Merck has been since 1992, will help the company lower operating expenses, “reduce the size of our operating footprint and increase agility,” CEO Kenneth Frazier said in a release. The 2,000 employees and contractors in Whitehouse Station will either move to Summit, about 26 miles away, or to other Merck sites in New Jersey.

NBTY adjusts guidance

[NBTY Inc.] expects sales for its fiscal 2012 to top out between 3.04% and 3.7% higher than the previous year, according to preliminary guidance issued Oct. 9. The supplement firm estimates sales for its fiscal year ending Sept. 30 will be between $3.05 billion and $3.07 billion, but notes these estimates are not audited yet. The firm expects to post the full fiscal 2012 financial results by Nov. 30 (Also see "NBTY Pegs Sports Nutrition To Help Offset Private Label Slump" - Pink Sheet, 5 Dec, 2011.).

“Message fatigue” on FDA risk communication agenda

FDA’s Risk Communication Advisory Committee discusses how best to communicate risks about regulated products at a meeting in Silver Spring, Md., Nov. 2. The discussion will include “approaches to avoid message fatigue” and “communication barriers such as prevention or warning fatigue or inaccurate risk perception,” according to a notice in the Federal Register. People interested in presenting at the meeting should contact the agency by Oct. 25.

MusclePharm backs off Beast branding

Bodybuilding product firm will stop using materials and selling products that infringe on Beast Sports Nutrition’s trademarks, including Beast and Beast Mode. The trademark infringement claims were based on Denver-based MusclePharm’s alleged unauthorized use and representation of Beast trademarks, according to Beast’s Oct. 7 release. The Boca Raton, Fla.-based firm filed the case in the U.S. District Court for the Southern District of Florida.