Endo Health Solutions is lobbying both sides of the political aisle for protection of its Lidoderm patch as Congress moves forward with bills to fund the U.S. Food and Drug Administration, according to a report in Wednesday's New York Times.

The Times reported that Endo hired a former Democratic Congressman to lobby Democrats and a former aide to Republican Rep. Fred Upton (Mich.), who leads the House committee overseeing FDA authorization, to urge Republicans to write rules into the legislation that would require greater testing of some generic products.

Endo is based in Chadds Ford. The prescription lidoderm patch is used for treatment of after-shingles pain.

The lobbyists working the halls of Congress, in this episode, are Bart Stupak, a former Michigan Democratic House member, and William R. Nordwind, who worked more than a decade for Upton, to lobby for language that differentiates patches from tablets or capsules, which are most common delivery method for generics and branded drugs. According to the report, Endo wants enhanced - meaning more expensive and time consuming - testing of generic patches.

Stupak and Nordwind are partners at Venable L.L.P., a large law firm.

“I don’t talk about my clients,” Stupak said, according to the Times, which added that Endo spokesman Kevin Wiggins was equally uncommunicative on the topic.

Wiggins has not replied to a request by the Inquirer for comment.

Endo has been fighting to protect the Lidoderm franchise in other ways. Mylan and Watson have submitted applications for generic versions of Lidoderm. Endo was fighting Watson in court over the patent language. Before the judge in the case reached a decision, the two sides announced a settlement Tuesday that could put off when Watson would market its patch after getting FDA approval.

A link to the Times story is here.

A link to the Endo 8K filing with the SEC is here.

A link to the Endo-Watson agreement, as part of that SEC filing, is here.

The U.S. Food and Drug Administration said Tuesday evening that consumers and health care professionals should be wary of counterfeit versions of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that are being sold on the Internet.

Brand-name Adderall is made by Shire Pharmaceuticals and is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, but Teva and other companies make generic versions approved by the FDA. The prescription drug is classified as a controlled substance, meaning pharmacists are supposed to keep closer track of how and when they dispense the drug.

The FDA said its preliminary lab tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. The correct version of Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. The FDA said the fake versions, instead of these active ingredients, contained tramadol and acetaminophen, which are ingredients to treat acute pain.

Adderall is currently on the FDA’s drug shortage list because of active ingredient supply issues.

The FDA said consumers should be wary of online sources.

"Rogue websites and distributors may especially target medicines in short supply for counterfeiting," the FDA statement said.

The FDA said that Teva's authentic Adderall 30 mg tablets are round, orange/peach in color, and have “ dp” embossed on one side and “30” on the other side of the tablet. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed.

If the pills don't look like that or they come in a blister pack, they should be considered fake.

Teva spokeswoman Denise Bradley said via email that the company learned of two examples.

"Both were purchased from illegal web sites, not through legitimate distribution channels," Bradley said. "We have reported to the FDA and continue to work with them on the investigation. We were alerted by a consumer who noticed misspellings on the fake product packaging. Our product is packaged in bottles. These fake product are packaged in foil wrappers."

The FDA asked consumers who think they received a counterfeit Adderall to contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989.

Teva Pharmaceuticals' new chief executive officer Jeremy Levin said Thursday morning that he has changed the leadership lineup in hopes of helping the global drug company regain more of the U.S. generic market in the face of increasing competition.

Chief financial officer Eyal Deshah said the company has "instituted a cost-cutting and efficiency program throughout Teva's operations," but a spokeswoman later said via email that there have been no layoffs, including in the Americas division, which encompasses facilities in the Philadelphia area.

Teva, which is based in Israel, has four regional divisions: Europe, the Americas, Asia and EMIA (Eastern Europe, Israel, the Middle East and Africa).

The Americas division is based at a facility in North Wales, Montgomery County, but it has other facilities in the Philadelphia region.

Allan Oberman, who had led Teva's EMIA division, will become leader of the U.S. generics division. Tim Crew, who previously guided that unit, is moving to a new global role in the organization, according to the spokeswoman.

Bill Marth, who joined Levin in Thursday's conference call with financial analysts, is the leader of the Americas group.

"Bill remains the head of the Americas," Levin said. "We have instituted an augmentation of the U.S. generics team and that was an important step for us to bring in the greater depth of management and greater capability there, to assist in what I believe we can do here, which is to rebuild that market share."

In a filing with the U.S. Securities and Exchange Commission, Teva said that it had about $4 billion in U.S. generic revenue during 2011, down 32% compared to approximately $5.8 billion in 2010.

UPDATE: Late Wednesday afternoon, an FDA panel voted 6-4 against recommending approval of the Johnson & Johnson blood thinning drug Xarelto for use in reducing blood clots.

As mentioned here earlier today, the panel was asked to wrestle with concerns that the drug caused fatal internal bleeding in too many patients in clinical trials and that too many participants dropped out of the trials without J&J figuring out what happened to them.

According to the Associated Press report from the hearing in Silver Spring, Md., the panel decided those concerns were too great to approve the application. The FDA does not have to follow panel votes, but usually does.

The drug is already available for other conditions, but approval would have expanded the market for J&J and its subsidiary, Janssen Pharmaceuticals.

From Wednesday morning:

The U.S. Food and Drug Administration's cardiovascular and renal drugs advisory committee will meet Wednesday to review whether the drug, rivaroxaban (brand name Xarelto) should be approved as a blood thinner to help patients with heart disease avoid blood clots, which can cause heart attacks and strokes.

The drug is made by Johnson & Johnson's subsidiary Janssen Pharmaceuticals, but J&J has a marketing deal with Bayer AG.

This application and hearing is to decide on whether the label - and advertising and promotion - can say Xarelto works as an anticoagulant. The FDA approved Xarelto last November to prevent stroke in patients with irregular heartbeat and Bloomberg noted that it is already prescribed for patients undergoing some joint replacement surgery.

The briefing materials were released Monday in advance of the meeting and the reviewer, Dr. Karen A. Hicks, said she would recommend approval, but with several concerns.

Among the first concerns is that a batch of patients in the trials died from internal bleeding. Another concern was that a batch of patients - 15 percent - in the trials dropped out before the study was complete and Janssen didn't adequately figure out why and what happened to enough of them.

"Please discuss how the quality of a study, the missing follow-up and other data problems, should be factored into the interpretation of study results," Hicks said in her report to the committee, though she noted that it is a common problem in studies of this sort.

The panel is likely to vote and the FDA usually follows the decision of advisory committees, but it does not have to. A final decision might arrive by the end of June.

The AP reported that Wells Fargo analyst Larry Biegelsen said he expects "a very heated debate" over Xarelto's safety at the panel meeting, but concluding with a positive panel vote.

The FDA briefing document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is here.

The Bloomberg story is here.

The Wall Street Journal story is here.

The University City Science Center announced it has opened a fifth-round of applications for its QED Proof of Concept financing program for life sciences and digital health technology.

Researchers at 21 universities and research institutions in Pennsylvania, New Jersey and Delaware can compete for funding and business guidance in hopes turning their project into a new and profit.

The program will award up to $200,000 to up to four projects, with 16 other projects getting advice from insiders in the business.

Auxilium Pharmaceuticals, Inc. of Malvern said Monday that it struck a marketing agreement with GlaxoSmithKline to help sell Testim, Auxilium's prescription testogerone gel for men.

GSK will use its much bigger sales force to promote the replacement therapy to doctors, particularly primary care physicians, who would write prescriptions for the drug. GSK already has a range of cardiovascular, metabolic and urology drugs that might be promoted to the same group of doctors.

GSK is based in London, but has a big Center City presence and facilities in the Philadelphia suburbs.

The two companies agreed on a baseline expectation of sales. GSK gets paid a portion of net sales that exceed the baseline, according to a statement from Auxilium. Depending on how things go, GSK could get paid more when the agreement ends on Sept. 30, 2015.

Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations, Auxilium said in a statement. Symptoms include decreased sexual desire with or without impotence, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis.

This drug was not tested on men under the age of 18.

According to Auxilium, Testim is a clear, topical gel containing 1% testosterone, the same type of hormone that is produced by the human body. The gel is applied once-daily to the upper arms and shoulders and is absorbed into the bloodstream, with the intention that it would help return testosterone to normal levels.

“Today, GlaxoSmithKline and Auxilium have forged a collaboration to expand our reach to U.S. physicians who treat men with low testosterone and its resulting symptoms, known as hypogonadism, which we believe is a prevalent, but poorly recognized condition,” Adrian Adams, chief executive officer and president of Auxilium, said in a statement. “While the Auxilium sales force has consistently performed well in an increasingly competitive environment, adding the strength and breadth of GSK’s U.S. commercialization organization will further enhance our sales efforts with U.S. physicians who treat this condition.”

Cheryl MacDiarmid, vice president of GSK’s cardiovascular/metabolic/urology business unit, said in the statement, “Urology remains one of GSK’s key therapeutic areas, and our sales professionals are well positioned to provide physicians with information on the treatment of hypogonadism. We look forward to our collaboration with Auxilium and adding Testim to our portfolio so we can help meet the needs of men with this condition.”

Clopidogrel - known in branded form as Plavix - is the blood-thinning drug taken by millions of people with heart disease to avoid heart attacks and strokes and it will soon be on pharmacy shelves as a generic drug.

Plavix was made through a partnership of Sanofi-Aventis and Bristol-Myers Squibb and had U.S. sales of approximately $6.7 billion for the 12 months ending March 31, 2012, according to IMS Health.

This drug is for people who have already had some history of heart disease and need to avoid clotting problems that might lead to further heart attacks or a stroke.

The U.S. Food and Drug Administration approved generic versions this week.

“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” Keith Webber, deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research said in an FDA statement after the approval was announced Thursday. “The generic products approved today will expand those options for patients.”

Pittsburgh-based Mylan Pharmaceuticals was the first to file an application for generic approval so it will have six months as the only generic on the market. Mylan said in a statement that it will begin shipping tablets immediately.

After six months, other companies can sell versions, so the generic prices will drop more then.

The FDA said that Teva Pharmaceuticals, Dr. Reddy's Laboratories, Gate Pharmaceuticals and Mylan were approved for 300 milligram tablets of clopidogrel. Teva, Apotex Corporation, Aurobindo Pharma, Mylan, Roxane Laboratories, Sun Pharma and Torrent Pharmaceuticals got approval for the 75 milligram dosage.

A link to the FDA primer on generic drugs is here.

McNeil Consumer Healthcare, the beleaguered Fort Washington drug maker, recalled more products on Thursday.

This time, McNeil recalled one lot of Imodium Multi-Symptom Relief, an over-the-counter medicine for diarrhea, gas, bloating and cramps.

The company said the 53,892 packages in that lot are likely still with wholesalers, so the recall is directed mainly to them. Some of the packages might be torn.

A company spokeswoman said McNeil has no safety concerns about the products in torn packages, but having been exposed to air, the medicine might not provide the intended benefits. She said the company had received no complaints from customers.

The lot numbers are on the side of the box. The recalled lot number was CMF023.

The latest recall continues a troubling trend for the Johnson & Johnson division, which has its headquarters in Montgomery County, and has had dozens of recalls in the last few years.

Production at the Fort Washington facility stopped in April 2010 and it remains closed while undergoing $100 million in repairs and renovations. The closure was prompted by dozens of recalls that led the U.S. Food and Drug Administration to step in and a federal court judge to approve the plan to fix problems.

Company officials said earlier this year that repairs to the Fort Washington plant will run at least through the end of 2013, meaning products won’t leave the facility until sometime in 2014.

The Imodium recalled Thursday was produced at the McNeil plant in Lancaster.

The plants in Lancaster and Las Piedras, Puerto Rico, are operating under increased scrutiny because of the agreements with the government. It is unclear if this latest recall will affect the Lancaster plant production in the future.

McNeil produces well-known brands such as Tylenol and Motrin.

“We’re obviously disappointed that it is taking a little longer to get back into the market,” Johnson & Johnson chief financial officer Dominic Caruso said on a conference call with stock market analysts on April 17.

If consumers end up with one of the broken packages, they can call the company’s customer service line for help with a refund. That number is 1-888-222-6036 and is available Monday through Friday, 8 a.m. to 8 p.m. Eastern Time.

A link to the recall notice is here.

Human Genome Sciences said Thursday that its board of directors again rejected the $2.6 billion takeover offer from GlaxoSmithKline.

The two companies have partnerships linking three of HGS's most-promising drugs, which might deter other potential bidders.

Still, HGS says the $13 per share offer is insufficient and urged shareholders not to sell shares to GSK.

GSK is based in London, but has a big Center City presence and facilities in suburban Philadelphia.

GSK had sought to takeover HGS in a friendly way, but after the first rejection, announced that it was going directly to shareholders.

“Our board of directors has concluded unanimously that the GSK offer is inadequate and does not reflect the value inherent in Human Genome Sciences,” HGS President and Chief Executive Officer H. Thomas Watkins said in a statement.

HGS said GSK was trying to take advantage of HGS's lower stock price in recent months and that talks have begun with other pharmaceutical companies.

"As part of this process, the company’s management, with the assistance of the company’s financial advisors, has engaged in discussions with a number of other parties, including major pharmaceutical and biotechnology companies, regarding a potential transaction, has entered into confidentiality agreements with certain parties and is providing those parties an opportunity to engage in a due diligence review of confidential information," the HGS statement said, without specifying which companies.

Thus far Thursday, GSK has not commented.

The HGS stock opened at $14.25 on Thursday. It's 52-week high was $28.38.

The bid for Human Genome Sciences is just the largest of a few recent moves by GSK to enlarge the empire.

The other day GSK said it completed acquisition of 10 million shares of Theravance common stock.

Earlier in the week, GSK said it spent about $98 million for the shares it didn't previously own of the privately-held company Cellzome. Cellzome does work in the proteomics technology area, meaning it researches and scans proteins to define their structures.