Will Ranbaxy sell its lipitor rights??

The most popular question among the analysts and trade specialists today is" Will Ranbaxy sell its Lipitor rights?" 

After winning the rights for 180 day exclusivity of Lipitor  in U.S(2008), Ranbaxy was considered to be sitting on a cake of profits. Although citing regulatory reasons, FDA withdrew its approval of several manufacturing plants of Ranbaxy, leading to wide speculations about the status of Lipitor. The generic copy of Lipitor was slated to be released on Nov.30, 2011, over which clouds of doubt reside!!


Lipitor is the highest-selling drug of all time, generating $10.7 billion last year. An FDA investigation into quality standards at two Ranbaxy manufacturing plants and a federal investigation into its testing practices have delayed approval of the drug copy. Federal prosecutors are negotiating a dispute settlement that may cost Ranbaxy more than $1 billion, Fortune Magazine reported in May.


If Ranbaxy doesn't get approval by Nov. 30, it  may postpone the release of its copycat Lipitor.This would also delay the timeline for other generic manufacturers wanting to sell their own copies, as Ranbaxy’s 180-day exclusivity period does not start until it begins commercial marketing.Mylan, actually tried to force FDA to nullify Ranbaxy's exclusive rights, given the company's difficulty obtaining approval, but a judge tossed out that lawsuit.


Alternativley, If the delay is lengthy, than Ranbaxy has got a chance to waive the exclusivity in return for payment from another drugmaker, either a lump sum or a piece of the sales,as reported by Bloomberg.
Ranbaxy, 64-percent owned by Tokyo-based Daiichi Sankyo Co., received a one-time payment from Boehringer Ingelheim GmbH last year for relinquishing its 180-day exclusivity on the Flomax prostate treatment under similar circumstances.


The officials at Daichi Sankyo refused to comment on the pending approval of lipitor by FDA. It remains to be seen which path Ranbaxy takes to come out of this situation. Till then, the markets would be abuzz with the question...."Will Ranbaxy sell its Lipitor rights?" 

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Sugar to fight against Hospital infections!!

A Carbohydrate found on the surface of one of the most virulent strains of Clostridium Difficile has been synthesized by scientists in Germany.
This piece of research can prove to be an important breakthrough in the Vaccine development programme against the infection.

C.Difficile bacterium

C.Difficile is a species of Gram-positive bacteria of the genus Clostridium that remains in a dormant form (i.e. spores) inside the colon until a person pops an antibiotic pill. The antibiotics in its course of action also destroys the normal gut flora(the good bacteria) leading to an overgrowth of C. difficile, which flourishes under these conditions. This results in the C.difficile getting converted into its active form and producing toxins which damages the gut wall, resulting in bloody diarrhoea and pseudomembraneous colitis.


C.difficile infections are one of the most common Nosocomial infections worldwide and are the leading cause of death in elderly and those with weakened immune system.Peter Seeberger, who led the team that carried out the research at the Max Planck Institute of Colloids and Interfaces, Potsdam was qouted as saying"C. difficile is on the rise in industrialised countries.There is a need for a vaccine but it's a big challenge."


Treatment with antibiotics is not so effective because of increasing resistance and tough nature of bacterial spores..The majority of severe infections are caused by just one hypervirulant strain - type 027.


To fight this particular strain, Seeberger and his team synthesised the repeating unit of a carbohydrate -pentasaccharide PS-1 - that is only found on the surface of type 027. The linear synthesis involved using one precursor molecule to make four different building blocks, making an efficient process. Their aim is to use PS-1 to create a vaccine to enable the immune system to recognise it, make antibodies against it and mount a response against the infection.

'It is elegant chemistry and shows that if you master the challenges of synthetic carbohydrate chemistry, you can produce something that's medically useful,' says Gerd Wagner, a medicinal chemistry expert at King's College London, UK, who agrees that the research 'opens the door to exploring a vaccine candidate'. 

Seeberger's team was also the first to synthesize PS-2, a carbohydrate found on all strains of C. difficile. He states the possibility of 'combining PS-1 and PS-2 in a single vaccine candidate for better coverage'. His team has begun tests using PS-1 attached to a protein carrier to determine whether animals can create antibodies against it. It will be years before a vaccine is available, he says, but he emphasizes that PS-1 and PS-2 are both promising candidates!!

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Schedule HX: A Proposed Solution to ever increasing problem of Antibiotic Resistance!!

No, we are not talking about any drug or a device that may help combat Antibiotic resistance, the extent of which has gone out of bounds due to the random popping of these pills by the people.

What we are talking about is a new Schedule(HX), an amendment to the Drugs & Cosmetics Act,1945  proposed by the Union Health ministry in a bid to prevent large scale misuse of antibiotics in the country.


Through this ,India plans to ban the availability and over-the counter sale of the latest generation of antibiotics from general pharmacies.The move is expected to end the obsession with popping a pill.


The ministry has identified a group of 70 antibiotics to be included in this restricted category of drugs. Currently, antibiotics are placed under the Schedule H of the D&C Act.  The new Schedule will require doctors and chemists to retain prescriptions so that the abuse of antibiotics could be checked from now onwards. Once the policy takes effect, doctors, while prescribing antibiotics, will have to issue two prescriptions to every patient and one copy should be kept for a period of two years by the chemists. The officials from the DCGI office or state regulatory authorities can, thus, audit these prescriptions at any time. Violations under the new Schedule may be punished with a fine of Rs. 20000 or up to two years of imprisonment.  Antibiotics would be categorised as non-restricted, restricted and very restricted. Each category would have a distinct colour code for the benefit of consumers


The schedule has two parts: 
Part A of Schedule HX has 16 drugs and antibiotics that shall be sold directly by drug manufacturers to the tertiary care hospitals.These drugs will have a label with a red box,and will be marked as for use in tertiary care hospitals only.Drugs include-Moxifloxacin,Meropenem,Ertapenem,Doripenem,Linezolid and Cefpirome,etc.


Part B of Schedule HX has 74 drugs and formulations that will carry the warning that it is dangerous to take this preparation except in accordance with medical advice and not to be sold by retail without the prescription of the doctor. Drugs include: Gentamicin,Amikacin,Penicillin,Oxacilin,Norfloxacin,Cefaclor and Cefdinir,etc.

A Union health ministry official said: We are ready with the notification to bring around 90 drugs under a new strict schedule so that they arent randomly used.They are the third and the final generation of antibiotics.Random popping of these pills would make people resistant against the last available generation of antibiotics. 



Seems the Indian Govt. has finally woken up from a slumber!!

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Setback for Teva Pharma as its MS drug laquinimod flunks in Ph3 Trials!!

Teva's late-stage oral MS drug laquinimod flunked the second of three Phase III studies, the latest in a series of disappointments.

Researchers for Teva recruited more than 1,300 MS patients in 153 sites around the globe for the BRAVO study. They were randomized in two groups, with one getting laquinimod and the other receiving a placebo. According to the researchers, the study backed up the findings of the first Phase III, which demonstrated a reduction in the risk of disability progression and brain tissue loss. But while the randomization process was done properly, the "placebo and treatment study groups showed dissimilarity in two baseline magnetic resonance imaging characteristics," Teva said in a statement. "According to a standard and pre-specified sensitivity analysis included within the original statistical analysis plan, when this imbalance was corrected laquinimod demonstrated a significant reduction in the annualized relapse rate."
Whether or not Teva can persuade regulators to overlook the Phase III pratfall, though, remains to be seen. Analysts were distinctly disappointed last April when laquinimod failed to lower the relapse rate as much as they had hoped for in Phase III. With Novartis's Gilenya on the market and Biogen Idec reporting late-stage success with its oral MS drug BG-12, an approval isn't enough to guarantee blockbuster sales. And some analysts this morning were quick to give Biogen Idec an improved position in the race for regulatory approval.

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