Medical Dynamics

Mixed Reviews For New Parkinson’s Drug (VisitBulgaria)
Ethicon Endo-Surgery launch one-handed articulating endocutter (MTBEurope.info)
Pfizer Won’t Share Wyeth’s Q3 Numbers; Layoff Announcements Due This Week (Industry.bnet.com)

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Eli Lilly Swings To 3Q Profit Amid Year-Ago Zyprexa Charge (Pink Sheet)

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Pfizer earnings up 26% despite lower sales of many drugs (Pharma Times)

Biogen profits leap as Tysabri sales soar again (Pharma Times)

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Sanofi-aventis’ new insulin injection more efficient (Trade Arabia)

Sanofi-aventis has announced the results of new analysis that found a significantly lower risk of nocturnal hypoglycemia with Lantus (insulin glargine [rDNA] injection) as compared to NPH insulin.
Merz Pharmaceuticals Announces Phase III Data for NT 201 in Post-stroke Upper Limb Spasticity (EarthTimes)

Data results published this month in Clinical Neuropharmacology, revealed that Merz Pharmaceuticals’ NT 201 (botulinum toxin type A free from complexing proteins), also known by the brand name Xeomin in Europe and Canada, was statistically significantly more efficacious than placebo for the treatment of patients with post-stroke upper limb spasticity. The Phase III study assessed the impact of NT 201 on muscle tone, functional disability and caregiver burden in patients with post-stroke upper limb spasticity, utilizing a randomized, placebo-controlled, double-blind design.
EU antitrust regulators raid drugmakers (Reuters)

EU antitrust regulators raided several pharmaceutical companies suspected of violating EU antitrust rules on Tuesday as they stepped up their crackdown on drugmakers seen as delaying the launch of cheaper medicines.
Sanofi’s Multaq Unlikely to Be a Blockbuster, Says Analyst (bnet.com)

Before Sanofi-Aventis launched its heart drug Multaq, some analysts estimated revenues would top €3 billion. But 10 weeks into the launch, Multaq looks like a much more modest affair, according to a note to investors from Jefferies International.

FDA Clears Hologic’s MammoSite ML Radiation Therapy System for the Treatment of Early-Stage Breast Cancer (Media Exhange)

 Human Genome: Journal Reviews Lupus Drug Endpoints Positively (Dow Jones)

NovaDel Article Published in Headache: The Journal of Head and Face Pain (Business Wire)

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The Pink Sheet “For Generic Vancocin, An Advisory Committee Role Reversal” August 3, 2009

The Pharmaceutical Science and Clinical Pharmacology Advisory Committee does not typically review specific drugs. But on Aug. 4, FDA’s Office of Generic Drugs will ask the committee for its advice on bioequivalence standards for ViroPharma’s Vancocin (vancomycin).

Currently OGD recommends that an applicant seeking marketing approval for generic vancomycin demonstrate bioequivalence to Vancocin through in vitro dissolution studies.

According to FDA’s briefing documents, Vancocin – which is indicated to treat staphylococcal enterocolitis and antibiotic-based associated pseudomembranous colitis caused by Clostridium difficile – is highly soluble over a wide range of pH values and acts locally in the GI tract. For this reason, comparing dissolutions rates in media of varying pH values which represent conditions in the GI tract is the most suitable approach for comparing generic vancomycin and Vancocin.

ViroPharma, however, argues that those requirements are essentially the Biopharmaceutics Classification System-based biowaiver, which was developed using healthy GI parameters to predict the absorption of systemically acting drugs from the healthy gut and was not intended for use in predicting in vivo performance of locally acting GI drugs.

In addition, the dissolution standard does not address the conditions of the in vivo environment of the diseased GI tract in which Vancocin is used, the brand firm argues. The generic’s dissolution and solubility would never be studied using relevant physiological conditions, including decreased fluid volumes, elevated pHs, and altered fluid composition.

In 2006, FDA issued BE recommendations for vancomycin capsules in a draft guidance, changing the standard from clinical endpoint studies to the in vitro dissolution BE method for BCS Class I drugs based on academic inquiry into the physiologic parameters of the healthy human GI tract. In light of that evidence, FDA waived the requirement that BE must be demonstrated with in vivo data.

Of the four BCS drug classes, FDA has extended the biowaiver to only BCS Class I drugs. In 2006, Vancocin was characterized as Class I and deemed eligible for a biowaiver.

However, ViroPharma insists that Vancocin is not a BCS drug at all. The BCS explicitly did not consider locally acting drugs such as Vancocin in its validation development, it argues, and furthermore, Vancocin is not rapidly dissolving.

Both FDA and ViroPharma’s briefing documents note that the shift to in vitro dissolution BE for vancomycin relied in part on faulty data from a generics company that showed vancomycin is rapidly dissolving. ViroPharma objected to the data and when FDA took a closer look, it confirmed that vancomycin is not rapidly dissolving.

In March of 2006, ViroPharma filed a petition with FDA, seeking to stay approval of all ANDAs that reference Vancocin, saying acceptance of in vitro bioequivalence standards was “fatally flawed” and should not have been issued without prior public discussion.

Most recently, ViroPharma has taken the unusual step of challenging the assertions in the agency’s briefing documents – most importantly the fact that Vancocin was approved based on dissolution studies, a point the sponsor emphatically denies. Other inaccuracies, according to a ViroPharma letter sent to the docket on July 31, include OGD’s misrepresentation of a historical document and misconstruing key facts regarding acarbose ANDAs.

When the committee met last summer to discuss bioequivalence, ViroPharma treated the panel as a make-or-break event in trying to convince FDA to change its approval standards.

During that meeting, ViroPharma was relegated to presenting data during the open public hearing, but this time the company will get equal billing as a presenter, although generic firms may present as well. But the fact that ViroPharma is inching its way up the agenda, instead of having to face generics in the marketplace, could be a sign that it’s making progress to get FDA to change its mind.

The Pink Sheet

“Schering Plough’s Saphris Gets Strong Nod From FDA Panel”

July 31, 2009

The atypical antipsychotic market should soon be seeing competition from a new entry with a novel formulation and a more attractive safety profile, after an FDA advisory committee voted strongly in favor of Schering Plough’s Saphris (asenapine) for acute schizophrenia and bipolar mania in adults at a July 30 meeting.

The Psychopharmacologic Drugs Advisory Committee found asenapine to be similarly efficacious to others in the atypical antipsychotic class and have a slightly better safety profile. The FDA panel voted unanimously that the risk-benefit balance was positive for the bipolar indication, and 9-1 with 2 abstentions that the balance was positive for schizophrenia.

They sited similar efficacy to other antipsychotics, a slightly better safety profile, the need for further treatment options for the difficult-to-treat patient populations, and the benefit of asenapine’s formulation as a sublingual tablet for patients that have trouble swallowing pills.

The sponsor did not come into the meeting facing an uphill battle. In briefing documents released prior to the meeting FDA stated its support for the safety and efficacy of asenapine compared to rest of the atypical class. And breaking with typical advisory committee protocol, the agency did not even make its own presentation of the data, instead saying it supported the sponsor’s conclusions

For the risk side of the equation in both indications, asenapine made a strong showing against a class of atypical antipsychotics known for a host of safety and tolerability issues.

Asenapine was not associated with any new or unexpected adverse events, and even demonstrated less impact on weight and metabolic parameters than some of its would-be competitors, including Lilly’s Zyprexa (olanzapine) and Johnson & Johnson’s Risperdal (risperidone), both of which served as active controls in the development program.

In terms of efficacy, the panel found it easier to vote on the bipolar indication than schizophrenia, voting unanimously that the bipolar studies were clearly positive for asenapine.

The primary concern pertaining to asenapine in bipolar disorder pertained to dose, and whether the drug could be efficacious at the 10 mg BID dose at which it was studied. Schering told the panel it is committed to conducting a postmarket study of asenapine at 5 mg BID for bipolar disorder.

Votes on the schizophrenia indication were a bit more scattered due to some confusion of how to interpret the overall efficacy signal over four trials. Two of the trials were positive for asenapine, but only one was positive for the dose the firm is proposing: 5 mg BID. The other trial tested asenapine at 10 mg BID, showing similar but no additional benefit to the 5 mg dose.

Of the other two trials, one was discounted as a failed study (showing no benefit for either asenapine or the active control against placebo) and the other was negative (with the active control, but not asenapine, superior to placebo).

Ultimately, they voted 10-2 that asenapine was effective for schizophrenia, comparable to other atypical antipsychotics. The two members who voted against approval cited concerns about the mixed signals across the trials, and the 60 percent drop-out rate in one of the trials (an attrition rate FDA said was typical for psychiatric trials).

The panel also voted 10-2 that the safety profile for the schizophrenia indication was acceptable, after determining that a vote against efficacy must logically lead to a vote against safety, despite a risk profile positive in comparison to others in the class.

In addition to the lower-dose study of asenapine in bipolar disorder, Schering assured the panel that it is also committed to conducting post-market pediatric studies for both indications.