Monday, November 12, 2012

The Year 2012 for the Pharma Industry - A Year of Blockbuster patent expiries or Blockbuster approvals !

In 2012, the year of patent cliff, the innovation driven pharma companies  went through the pain of losing the largest of their blockbusters to generic competition.   Approximately $40b in revenue from small molecules was impacted by generic competition and this proved to be a bonanza for the payors and the generic pharma industry. 

But  in the midst of  all these painful patent expiries, the pharma industry delivered to the world a set of new blockbusters. These new innovative drugs have set new standards in the treatment of various diseases.  

Perjeta and Afinitor have set new benchmarks in the treatment of breast cancer

For the breast cancer patients, two new drugs - Perjeta and Afinitor were approved. The extent of survival benefit demonstrated by Perjeta and Afinitor have set new benchmarks in the treatment of Her2+ve and HR+ve breast cancer patients respectively.  Novartis expects Afinitor to generate an incremental $2billion sales from breast cancer alone. Afinitor is approved for several other indications (renal cell carcinoma, pancreatic neuroendocrine tumor, tuberous sclerosis complex and tuberous sclerosis complex )
On 8th June 2012, USFDA approved Perjeta, ahead of the PDUFA date for use as a first-line treatment metastatic HER2-positive breast cancer in combination with Herceptin (trastuzumab) and docetaxel. The approval was granted based on extraordinary benefit demonstrated in the Phase 3 pivotal trial. Perjeta extended the time patients live without their disease progressing by 6 months (18.5 months versus 12.4 months). According to medical oncologists the increase in median progression free survival of over six months is a significant advance in the treatment of HER2-positive metastatic breast cancer.

Similarly Afinitor which as well received USFDA approval recently delivers path breaking benefit in HR+ve breast cancer post menopausal women who have been previously treated with aromatase inhibitors.
Afinitor approval was based on the results of a double-blind, placebo-controlled Phase III study (BOLERO-2) that included 724 postmenopausal women with advanced HR+ breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole. In the study Afinitor more than doubled the time patients lived without their disease progressing. Patients treated with everolimus plus exemestane had a median progression-free survival (PFS) of 7.8 months, compared to 3.2 months for those treated with exemestane alone.

First in class and  Best  treatment for Hypertriglyceridemia approved

Until 2012, GSK's Lovaza was the only one omega-3 prescription drug that had FDA approval for this indication and it generated blockbuster sales. In July this year, the USFDA approved Amarin's Vascepa (AMR10) for the treatment for hypertriglyceridemia.
Hypertriglyceridemia is a large market - In the U.S. alone, approximately 4 million people have triglyceride levels above 500 mg/dL and Vascepa by virtue of its superior clinical profile should be able to well exceed blockbuster sales.

Vascepa is significantly better than the existing marketed agent Lovaza (omega-3-acid ethyl esters; a product of GlaxoSmithKline). It has all the attributes to be successful. It is more efficacious than Lovaza in cutting down the very high triglycerides levels, and this comes without the drawbacks of Lovaza, which elevates low-density lipoprotein (LDL) cholesterol and leaves a fishy aftertaste, common among omega-3s. .

With promising efficacy data and a favorable side effect profile, Vascepa is clearly a blockbuster

The long wait of Obese patients for a  new treatment option  finally came to an end in 2012

Obesity, so far has been undertreated primarily because there are not very efficacious and safe treatment options. But in 2012 obese patients had a sigh of relief, as after a long wait of over 13 years, they saw approval of two new treatment options for them - Belviq and Qnexa.  These newer treatment options offer robust efficacy when compared to Xenical, which was the the only approved prescription drug for obesity on the market until then.
Obesity is  be the mother of many chronic diseases (diabetes and hypertension) and companies have burnt billions of dollars in reaching to a drug that would pass through the high regulatory hurdles of the USFDA in this indication. USFDA has traditionally been cautious on obesity drugs, as many of the drugs that were approved for weight loss had to be withdrawn from the market due to safety issues. In 2010, the USFDA issued a liver safety warning on Xenical. 

Diabetes patients can take a break from frequent injections

Managing blood sugar levels and taking regular injections has always been a pain for diabetes patients. To their relief, for the first time we saw the approval of once weekly treatment - Bydureon. Bydureon  is a novel formulation of already approved exenatide (Byetta) and  belongs to the class of drugs called GLP-1.  Besides compliance benefit, robust efficacy, Bydureon also offers to patients a better tolerability profile as it has lesser gastrointestinal side effects, which is more frequent with other GLP-1's on the market (Victoza and Byetta) prior to the approval of Bydureon. To further enhance patient convenience, Amylin (BMY / AZN now) will shortly roll out a pen version of Bydureon to replace the syringes.  Currently patients need to fill their own syringes and inject themselves, however, availability of pre-filled, fixed-dose pen for delivery could expand Bydureon adoption and boost patient adherence.

Now Methotrexate refractory RA  patients have an oral treatment option as well

Existing treatment options for the Methotrexate refractory RA patients are  injectables (once fortnightly / weekly), while Tofactinib would be the first oral treatment  (twice daily) in this space.

On November 6th , the U.S. Food and Drug Administration  approved  Xeljanz (tofacitinib) a twice daily oral drug , first in class JAK inhibitor -  to treat adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response or who are intolerant to methotrexate.  In terms of efficacy and safety, tofacitinib is as good as the existing treatment options, and also offers the advantage of oral dosing. In a head to study comparing Tofacitinib to the Humira - gold standard treatment for methotrexate refractory RA, it demonstrated comparable efficacy and safety. 

Pfizer has priced tofacitinib at a 7% discount to Enbrel, which would reduce patients cost and the burden on healthcare system.

First in class SGLT2 inhibitor for type 2 diabetes- Forxiga or Dapagliflozin approved by EMA

On November 14th, AstraZeneca and Bristol-Myers Squibb Company announced that the European Commission has approved  FORXIGA™ (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). FORXIGA is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes. 
Forxiga Promises Unique benefits over existing treatments and it should be able to quickly carve into the market share of existing drugs and gain blockbuster sales. The most important benefit that Forxiga promises is weight loss, which no other oral treatment option delivers. Besides Forxiga acts by inhibiting absorption of glucose in the kidneys and hence will allow synergistic action when combined with a sulfonylurea or a DPP-IV inhibitors which act by promoting the release of insulin. Unlike sulfonlyureas, Forxiga does not cause hypoglycemia.
Forxiga also makes an excellent add on to insulin. Patients on insulin suffer from two major issues 1) Weight gain and 2) Hypoglycemia. Adding Forxiga to insulin would allow insulin patients to shed weight instead of weight gain. Besides Forxiga does not cause hypoglycemia and hence can be safety added to insulin therapy

Eliquis (Apixaban)  - The New Gold Standard Treatment for Stroke Prevention in Atrial Fibrillation approved in Europe

Eliquis which belongs to a class of drugs called Factor Xa inhibitors is a new generation oral anticoagulant / blood thinning drug and is expected to replace warfarin the current gold standard treatment for stroke prevention in atrial fibrillation. Besides Eliquis, two other new generation oral anticoagulants - Bayer's (BAYRY.PK) / Johnson and Johnson's (JNJ) Xarelto (approved in 2011) and Boehringer Ingelheim's Pradaxa (direct thrombin inhibitor, approved in 2010) are also on the market and are vying to replace warfarin.
The clinical data on Eliquis in atrial fibrillation is most impressive, when compared to Xarelto or Pradaxa and looks all set to grab majority market share. You can see a cross trial comparison of Pradaxa, Xarelto and Eliquis here.  Compared to other anticoagulants on the market, Eliquis is the only anticoagulant to have demonstrated statistically significant superiority over warfarin in the reduction of the composite of stroke / Systemic Embolism / all-cause death and major bleeding. 
The peak sales of Eliquis can well cross pass $5billion

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