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GLG News by Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

Aemad AslamPresidentMindPharma What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Thriving in a time of adversity - Sun Pharma pounces on shortage by getting approval on Oxycodone

April 13, 2009

Sun Pharma gets USFDA's nod to market painkillers | www.hindu.com

Sun Pharma can greatly benefit from the nationwide shortage of Oxycodone Immediate Release Tablet, by getting approval from the FDA on their own generic. With recent recalls from different manufacturers, and the shortage of a comparable product Morphine Sulphate, the FDA currently estimates that return to normal supply levels of Oxycodone may occur in approximately 2 months, during which time Sun Pharma can capitalize on the shortage by securing longer term contracts with wholesalers.

Aemad AslamPresidentMindPharma What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Aurobindo Pharma's Escitalopram will be a big mover ... when it comes out in 2011

March 5, 2009

Aurobindo Pharma receives tentative approval for Escitalopram | www.indiainfoline.com

Forest's Lexapro commands a $2.5+ billion USD market share, just in the US.  Due to such a high volume of the brand product, Aurobindo's tentative approval on Lexapro's generic Escitalopram will be a great opportunity - primarily if they can procure a 6 month period of exclusivity from the FDA.  Additionally, despite being a brand name product, Lexapro holds an 8%+ year over year increase in the past 3 years.  Hence, the market for the drug in September of 2011 when the patent runs out will be closer to a $3 billion market.                

Aemad AslamPresidentMindPharma What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Teva's Generic Imitrex commands market of Sumatriptan

February 26, 2009

Teva Announces Approval and Launch of Generic Imitrex(R) Tablets | www.pipelinereview.com

With the 180 day exclusivity, Teva is already commanding the market of the generic Imitrex - Sumatriptan oral tablets.  Teva maintains an AB rating of the generic that will render most insurance companies to push brand name Imitrex by GlaxoSmithKline to a non-formulary tier, skyrocketing the generic's sales.  Already, different wholesalers are reporting a backorder on Teva's generics.  Additionally, Teva's pricing point is very favorable to itself, despite Dr Reddy's prior entrance.

Aemad AslamPresidentMindPharma What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Acquisitions of Indian Pharma on the extended horizon by Brand name pharma

February 23, 2009

Pharma cos on lookout for Indian drug firms | economictimes.indiatimes.com

Acquisitions of various Indian generic pharmaceuticals is likely on the horizon for brand name manufacturers.  However, this is not an immediate concern.  I would see more consolidations in the US and other Western markets first. 

Aemad AslamPresidentMindPharma What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Sun Pharma - much stronger with acquisitions including Taro

February 17, 2009

As valuations dip, Sun Pharma is in M&A mode | economictimes.indiatimes.com

Sun Pharma is attempting to gain market share in the world largest market - the US market.  Sun Pharma is clearly expanding it product base with venturing into topical (dermatological) and pediatric segments, and with vertical integration as with raw materials suppliers.  Sequentially, I would see SunPharma to be a leader in the US market within this decade, unless other Indian manufacturers encroach in this market.                     

Aemad AslamPresidentMindPharma What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Aurobindo's Terbinafine Tablets? Not a news maker

January 26, 2009

Aurobindo Pharma gets approval for Terbinafine Tablets | myiris.com

Aurobindo's approval of Terbinafine tablets is already entering a saturated market as the tenth entrant.  Accordingly, with strong pressures from other Indian manufacturers as Dr Reddy's and Wockhardt, this has very little profit margin potential.  Such reduced pricing is aiding the wholesalers as McKesson (MCK) or Cardinal (CAH) by negotiating an even lower acquisition cost.  Reduced pricing is already evident, as Terbinafine has been on Walmart's (WMT) $4 generic list for some time.

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Risk/Benefit is the Answer, Even More Now

December 22, 2008

Tysabri - Multiple Sclerosis patient with progressive multifocal leukoencephalopathy has died | www.msrc.co.uk

1. In general, the more pharmacologically potent a therapy, the more the possibllity that adverse experiences will be seen. 2. Risk/Beneift is a critical consideration, even for products intented for serious or life-threatening disease. It is incumbent upon both the FDA and the physician community to realistically assess preclnical and clinical data during the review and approval process. 3. Patients must be fully and competently informed of the risks and benefits of such therapies and have the right to decide for themselves whether or not to participate in clinical trials and therapeutic treatment with marketed products. 4. No therapeutic regimen is risk-free and society needs to understand and embrace this fact.

David Zimmerman, President/Owner

David ZimmermanPresident/OwnerDoctors of Pharmacy, Inc. What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Tamper Proof Narcotic Pain pill? YES

November 13, 2008

FDA Asks if Pain Pill Is Tamper-Proof | online.wsj.com

This drug will allow patients in severe pain to get the necessary pain relief and not have to worry about the other patients that abuse the drug.

Joseph Bertino, Independent Consultant

Joseph BertinoIndependent ConsultantBertino Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Gene Targeted Drug Therapy for Heart Failure

September 23, 2008

Gene Targeted Drug Therapy for Heart Failure | www.bio-medicine.org

-Another step towards invididualized medicine -Proves that old drugs can be reinvented for useful purposes -Advances pharmacogenetics forward

Eric Gruff, Principal

Eric GruffPrincipalE4 Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Link to Pancreatitis is Bound to Negatively Impact Byetta Sales

August 21, 2008

FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov

The recent publication of new cases of pancreatitis that are occurring in patients taking Byetta (exenatide) can't be good for Amylin/Lilly. While Byetta and investigational GLP-1 analogs are still very viable therapeutics for Type 2 Diabetes, prescribers will have to reassess the risk-benefit ratio for many patients given the new information. The long-acting form of Byetta (LAR) may suffer the most since its long half-life will make reversal of pancreatitis that much more difficult and may lead to additional damage.

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