Sunesis Pharma gets European orphan drug status for vosaroxin to treat AML – pharmabiz.com

Sunesis Pharmaceuticals, Inc., a biopharmaceutical company, has received orphan drug designation from European Commission to its lead development candidate, vosaroxin, for the treatment of acute myeloid leukaemia (AML).

The designation provides for 10 years of marketing exclusivity in all EU member countries following product approval. Vosaroxin has previously received orphan drug and fast track designations from the US Food and Drug Administration (FDA).

“The European Commission’s decision reinforces the global potential of vosaroxin and recognizes the desperate need for new treatment options in AML, an indication for which treatment standards have not changed appreciably in the past thirty years,” said Dr Adam Craig, EVP Development & CMO of Sunesis. “European orphan drug designation is the latest in a series of regulatory milestones that have strengthened the commercial opportunity for vosaroxin on both sides of the Atlantic. These include the potential for market exclusivity to 2030 and an expedited review process in the US, as well as new patents issued in the European Union with exclusivity to 2025.”

As established by the European Medicines Agency (EMA), orphan designation is granted to product candidates intended for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. It also provides for scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and certain financial incentives for companies developing orphan drug candidates. Orphan drugs are eligible for a reduction of fees associated with pre-authorization inspections, as well as marketing authorization application fees and certain other fees for qualifying companies.

Sunesis is currently enrolling patients in its VALOR trial, a phase III, multinational, randomized, double-blind, placebo-controlled, pivotal clinical trial of vosaroxin in combination with cytarabine in first relapsed or refractory acute myeloid leukaemia.

VALOR is a phase III, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at approximately 110 leading sites in the US, Canada, Europe, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broader range of survival outcomes. The trial’s primary endpoint is overall survival.

Vosaroxin is a first-in-class anti-cancer quinolone derivative, (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.

Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers.

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Pharma stocks a defensive play, says Bhat – Moneycontrol.com

Published on Fri, May 04, 2012 at 18:34 |  Source : CNBC-TV18Updated at Fri, May 04, 2012 at 18:47   54893 Investors following Ranbaxy Labs. Share this News with them.0

One can buy defensive stocks like pharma says Dilip Bhat, Joint MD, Prabhudas Lilladher.

Bhat told CNBC-TV18, “We would be more comfortable towards pharmaceutical. It is a great space to be in even now particularly Ranbaxy and Dr. Reddy’s and in the midcap it could be Indoco Remedies.”

He further added, “ Ranbaxy Labs is one story which we are just in the process of doing a detailed coverage but that’s one stock which we feel has a potential to double over next 15-18 months. I think with the FDI approval coming, the stage is set for the core profits to really grow in a very big way for the company and of course the first to file will keep on increasing the cash flows for the company. So that pharmaceutical space looks pretty good, interesting, defensive at the same time chances of getting a reasonable return also appears to be pretty good.”

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Valeant Pharma to buy University Medical's OTC brand AcneFree and certain … – pharmabiz.com

Valeant Pharmaceuticals International, Inc.,a multinational specialty pharmaceutical company,  has agreed to acquire certain assets from University Medical Pharmaceuticals Corp., a specialty pharmaceutical company focused on skincare products, for approximately $64 million plus potential milestones based upon attainment of future revenue targets. University Medical’s main brand is AcneFree, a leading retail over-the-counter (OTC) acne treatment.

Total revenue in 2011 from the acquired assets was approximately $32 million. The transaction is expected to close by mid-year, subject to certain closing conditions including expiration of requisite regulatory waiting periods, and is expected to be immediately accretive.

“The addition of a leading OTC acne treatment will provide us with the ability to expand our OTC business,” stated J Michael Pearson, chairman and chief executive officer. “We believe that we can build upon our success with CeraVe in the retail channel through increased offerings to consumers. These new products will be immediately accretive to our operations and have not been factored into our 2012 financial guidance.”

Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.

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Buy Alembic Pharma; target of Rs 86: Nirmal Bang – Moneycontrol.com

Published on Sat, May 05, 2012 at 10:48 |  Source : Moneycontrol.comUpdated at Sat, May 05, 2012 at 11:14  0

Nirmal Bang is bullish on Alembic Pharma and has recommended buy rating on the stock with a target of Rs 86 in its May 2, 2012 research report.

“Alembic Pharma, sequential results are not comparable due to seasonality factor. Q4 is seasonally weak quarter for the company. Exports drove the sales growth for the quarter as well as for FY12. During the quarter exports grew by 28.1% yoy as compared to domestic growth of 7.5% yoy. For FY12 exports reported impressive growth of 41.2% as compared to 11.3% domestic growth. During the quarter R&D expenses have increased substantially to Rs 22.1 cr (6.5% of sales; includes one-time filing cost of NDA of Rs 5 cr) as against Rs 9.1 cr (2.4%) in Q3FY12 and Rs 15.7 cr (5.3%) in Q4FY11, on account of higher filings for European and Brazil regions and more Para IV and 505 (b) (2) filings. We have also incorporated higher R&D cost for future years (4.8% of sales in FY13E and FY14E as compared to 4.0% in FY12).”

“The company has filed four ANDAs and three DMFs during the quarter taking the cumulative filings to 45 ANDAs and 62 DMFs. It has received two approvals as well in Q4FY12 taking the total approvals to 19. Management expects domestic formulations growth to be strong however it would be limited by current capacity constraints. The management expect 15% growth in FY13 however it also feels that FY14 would be the turnaround year in terms of growth as new capacity would ease the current constraints and it would be able to take the full benefit of increasing demand.”

“For FY12-14, we expect Alembic Pharma’s revenues to grow at 15.6%. However, PAT is expected to grow faster i.e. 25.0% during the same period on account of favorable change in product mix, shift from API to formulations, launch of new products and higher economies of scale. We had initially recommended Alembic Pharma on 22nd March 2012 at Rs 43. Since then the stock has given 26% returns. We maintain our “BUY” with a revised target price of Rs. 86 (earlier Rs 97) indicating a potential upside of 59% over next two years. Major reason for revision in numbers is slow down in FY13 numbers due to constraints in capacity and higher R&D expenses,” says Nirmal Bang research report.  

Non-Institutions holding more than 90% in Indian cos   

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To read the full report click on the attachment

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Textile, pharma to get astro support: Astrostocktips – Moneycontrol.com

Published on Fri, May 04, 2012 at 09:38 |  Source : Moneycontrol.comUpdated at Fri, May 04, 2012 at 09:41  Like this story, share it with millions of investors on M30

By Satish Gupta of Astrostocktips

Today’s planetary position: Moon will be transiting in Virgo, Mars in Leo, Exalted Saturn in Libra. Sun & Jupiter in Aries.  Ketu & Venus in Taurus. Rahu in Scorpio.  Mercury in Pisces, Pluto in Sagittarius, Uranus in Pisces. Neptune in   Aquarius.

RAHU KAL TIME: – 10.30-12.00

Predicted with blessings of Lord Ganesha on 21st March 2012 “With the change in planetary position, LIQUOR sector will be receiving very strong astrological support. Accumulate United Spirit on dips” United Spirit was quoted around Rs 538 at that time. In a period of one month it appreciated by 45%. This sector will continue receiving astrological support.(21.04.12)

Looking to the planetary configuration following sectors will be getting astrological support:

Textile: Raymond, Arvind, Century & Bombay Dyeing etc

Pharma: Dr Reddy, Lupin & Cipla ect

Buy Titan on dips.

Note: Prediction about Infrastructure sector was made by us 3 months back on Zee Business on last Deepavali day.

New Samvat 2069 (Hindu New Year) will start from 23rd March 2012. Whenever New Samvat starts, based on planetary position / conjunction & aspect among planets, some new sectors commence out performing & many sectors, which were in momentum during last Samvat start underperforming.

It has been observed many times that investors / traders (not knowing this fact) keep investing /trading in such sectors,( whose astrological support is over) ?” resulting in  losses. It is suggested to consult your Financial Astrologer to know about the sectors.

Bullish trend started in Silver from 1stSeptember 2010, when Saturn entered Hast Nakshatra. On 28th August 2010, silver was quoted Rs 28700 /kg. In a period of less than 1 year it appreciated by 3 times approximately. Now on 20th September 2011, Saturn has left Hast Nakshatra & due to this change in planetary position, long term bullish trend in Silver is over for time being. Now, only when Saturn will have some combination with moon along with other planets, it can move up for shorter period.

One should trade only in the stocks of that sectors which are getting very strong astrologically support, since the chances of losing money in such stocks are very less.

Sectors which get strong ASTRO support are not normally affected by downfall in the market.

Although we predict sectors, it is not necessary that all stocks with in same sector should move up same day.

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Quark Pharma extends pact with Pfizer to develop compounds containing … – pharmabiz.com

Silence Therapeutics Plc, a leading international RNAi therapeutics company, announced that its partner, Quark Pharmaceuticals, has extended its existing exclusive Licensing Agreement with Pfizer.

This amendment will enable Quark to perform a phase II a clinical study to assess the effect of PF-655 in a new indication, looking at visual function in patients with moderate and advanced Open-Angle Glaucoma (OAG). PF-655 incorporates Silence’s AtuRNAi technology and was sub-licensed to Pfizer by Quark in 2006, and on which Silence is entitled to receive a share of milestones and royalties that may be earned by Quark in the future on this compound.

The OAG study will be conducted in parallel with a Phase 2b study of PF-655 in diabetic macular oedema.

Silence has previously announced that it stood to receive up to $95m from Quark in relation to its licensing agreement with Pfizer. As a result of this amendment to the Quark/Pfizer license, Silence anticipates its share of these payments could now reach $120m. Silence has previously announced the receipt of $6m from Quark in relation to this licence.

Commenting on the announcement, Tony Sedgwick, Chief Executive Officer of Silence, said: “This is an exciting development for Silence. This will create a fifth external clinical programme using Silence’s IP and AtuRNAi, which is funded and managed by one of our partners. This will increase the potential share of milestones and royalties that Silence can earn under its agreement with Quark and is a further validation of the Silence technology.”

Quark and Pfizer have amended their existing exclusive Licensing Agreement on May 1 in order to enable Quark to perform a phase II a clinical study to assess the effect of PF-655 on visual function in patients with moderate and advanced Open-Angle Glaucoma (OAG). This study will be conducted in parallel with an ongoing phase II b study (QRK202) in diabetic macular edema (DME). The OAG study will evaluate the potential of PF-655 to enhance visual function in glaucoma. Under the amended agreement, should Pfizer assume development and potential commercialization of PF-655 in either or both indications following review of the Phase 2a PF-655 data, Quark will receive option exercise payments and be will eligible to receive development and regulatory milestones specific to each indication, as well as sales milestones and royalties. Quark may be eligible to receive additional total payments of up to approximately $165 million associated with development and approval of PF-655 for OAG.

Preclinical studies of PF-655 conducted by Quark suggest the potential of the compound as a neuroprotective and potentially neuroenhancing agent in diseases such as OAG, by preventing optic neural cell apoptosis and stimulating optic neural cell regeneration. In addition, in a Phase 2a study in patients with DME (Pfizer DEGAS study #B0451004), repeated injections of PF-655 showed a dose-dependent increase in visual acuity independent of changes in retinal thickness. The beneficial effects of PF-655 on visual function may potentially be due to effects on retinal cells themselves, rather than on vascular permeability.

The OAG study will be a Phase 2a, multi-center, double-masked, randomized, repeat dose, safety, tolerability and efficacy study in up to 108 patients with moderate and advanced OAG. In addition, Quark is currently conducting a Phase 2b study (QRK202) in DME patients testing higher doses of PF-655 alone and in combination with Lucentis(R) to further evaluate the safety and efficacy of PF- 655 in DME and to determine the optimal dose for pivotal Phase 3 studies.

Daniel Zurr, Ph.D. President and Chief Executive Officer of Quark stated: “We are very excited to evaluate the effect of PF-655 on visual loss in glaucoma in future clinical studies. The mechanism of action and biological activity of PF-655 are novel and its axon regenerating effects may provide a long awaited breakthrough in the treatment of glaucoma. We are pleased and grateful to our partner, Pfizer, for their support in pursuing this new indication.”

Quark Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company engaged in discovering and developing novel RNA interference (RNAi)-based therapeutics.

Silence Therapeutics plc is a leading biotechnology company dedicated to the discovery, development and delivery of targeted, systemic RNA interference (RNAi) therapeutics for the treatment of serious diseases.

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Sunesis Pharma gets European orphan drug status for vosaroxin to treat AML – pharmabiz.com

Sunesis Pharmaceuticals, Inc., a biopharmaceutical company, has received orphan drug designation from European Commission to its lead development candidate, vosaroxin, for the treatment of acute myeloid leukaemia (AML).

The designation provides for 10 years of marketing exclusivity in all EU member countries following product approval. Vosaroxin has previously received orphan drug and fast track designations from the US Food and Drug Administration (FDA).

“The European Commission’s decision reinforces the global potential of vosaroxin and recognizes the desperate need for new treatment options in AML, an indication for which treatment standards have not changed appreciably in the past thirty years,” said Dr Adam Craig, EVP Development & CMO of Sunesis. “European orphan drug designation is the latest in a series of regulatory milestones that have strengthened the commercial opportunity for vosaroxin on both sides of the Atlantic. These include the potential for market exclusivity to 2030 and an expedited review process in the US, as well as new patents issued in the European Union with exclusivity to 2025.”

As established by the European Medicines Agency (EMA), orphan designation is granted to product candidates intended for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. It also provides for scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and certain financial incentives for companies developing orphan drug candidates. Orphan drugs are eligible for a reduction of fees associated with pre-authorization inspections, as well as marketing authorization application fees and certain other fees for qualifying companies.

Sunesis is currently enrolling patients in its VALOR trial, a phase III, multinational, randomized, double-blind, placebo-controlled, pivotal clinical trial of vosaroxin in combination with cytarabine in first relapsed or refractory acute myeloid leukaemia.

VALOR is a phase III, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at approximately 110 leading sites in the US, Canada, Europe, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broader range of survival outcomes. The trial’s primary endpoint is overall survival.

Vosaroxin is a first-in-class anti-cancer quinolone derivative, (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.

Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers.

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Indian pharma companies like Hetero, Alembic, Lupin, Dr Reddy's dominating US … – Economic Times

Indian pharma companies like Hetero, Alembic, Lupin, Dr Reddy’s dominating US generic space – Economic Times You are here: Home>Collections>AlembicIndian pharma companies like Hetero, Alembic, Lupin, Dr Reddy’s dominating US generic spaceRupali Mukherjee, TNN May 4, 2012, 05.57AM ISTTags:Sun Pharma|Nectar Life Sciences|Lupin|Hetero|Glenn Saldanha|Glenmark Pharma|Dr Reddy’s|Alembic

MUMBAI: India is playing a dominant role in the US generic pharma space, having cornered over half the certified dossiers filed globally for active pharmaceutical ingredients (API). Drug companies from India filed 51% of the overall global applications, also called drug master filings (DMF), in the US market during calendar year 2011. DMFs are essentially approvals to supply complex raw materials to all generic manufacturers servicing the US market, which is the most lucrative of all global markets.

Over the last three years, there has been a sustained increase in the trend of such applications from India. Of the global DMF filings in the US, India accounted for 45% in 2009, which increased to 49% in 2010 and 51% in 2011 (see chart).

Against this, China which is the leading API supplier in emerging markets, cornered only 18% of the total DMFs filed in the US in 2011, down from 20% in 2010. Interestingly, midrung companies like Hetero, and even smaller ones like USV, Nectar Life Sciences, Shilpa Medicare and Gland Pharma are now filing for such approvals from the US Food and Drug Administration.

Says Glenn Saldanha, chairman and MD, Glenmark Pharma, “Indian companies are playing a huge role in providing tangible, long-term value to generic players in the US market. US being the largest standalone generic market, continues to offer attractive partnership opportunities as most US dosage manufacturers (barring the top four or five) are not backward integrated.”

Among the companies, Hyderabad-based Hetero had the maximum new filings at eight during the fourth quarter of 2011.Others like Alembic, Emcure and Gland have filed four DMFs each. Among large players, Lupin and Dr Reddy’s filed three each, while Sun Pharma had two filings, and Cadila filed for one. Other significant filers were Jubilant, Aurobindo, Ipca (two each), while Orchid and Torrent filed for one each.

It was the first time that domestic players filed for 22 molecules during the quarter (higher than eight in 3Q11), of which the Prasugrel filing by Dr Reddy’s may lead to a new chemical entity, according to a JM Financial analyst.

Says Sujay Shetty, partner, PwC India, “Domestic companies have moved up the value curve by filing complex certified dossiers. These filings are important for domestic as well as US companies, which are filing for approvals to launch generic drugs (abbreviated new drug application), and are truly indicative of the quality and regulatory compliance, which has become critical. Also, for Indian manufacturers in the US, sourcing APIs from Indian companies, lowers costs.” Sales of APIs in the US have also started augmenting US revenues of these Indian companies .

In the past, industry experts say domestic companies targeted less-regulated markets for API and this space is now extremely competitive. So, many of them decided to make the transition of supplying APIs to regulated markets. And to do this they naturally had to build on their R&D capabilities to meet the stringent requirements of countries like the US.

“Basically, two aspects have emerged… Not only are Indian companies offering standalone APIs but are also increasingly offering finished dosages as part of vertically integrated partnership deals. This is most true for mid-rung players which presently do not have a direct presence in the US market ,” adds Saldanha.

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Aventis Pharma net drops 20%; Piramal Healthcare posts loss – Livemint

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Sun Pharma stock rises after US court verdict – Business Standard

Sun Pharma stock rises after US court verdictPress Trust Of India / Mumbai Apr 19, 2012, 00:49 IST

The stock of the country’s most-valued drug maker, Sun Pharmaceutical Industries, closed with over two per cent gain on bourses, after a favourable verdict from the US Supreme Court in its patent case against Novo Nordisk.

The US Supreme Court ruled in favour of the company’s subsidiary, Caraco Pharmaceutical Labora-tories, in its patent litigation against Novo Nordisk over Caraco’s generic version of prandin, repaglinide tablets, used for treating diabetes.

Shares in Sun Pharma surged 2.8 per cent to Rs 600.5, its 52-week high on the Bombay Stock Exchange. The stock finally closed 2.1 per cent up at Rs 596.6. A similar movement was witnessed on the National Stock Exchange, where the stock opened at Rs 588.05, surged to an intra-day high of Rs 601.5, and finally closed at Rs 598 — a gain of 2.27 per cent.

The market capitalisation of the company increased to Rs 61,775 crore from Rs 60,020 crore yesterday.

The market capitalisation of the company increased to Rs 61,775 crore from Rs 60,020 crore yesterday.

Prandin is a registered trademark of Denmark-based drug firm Novo Nordisk and has annual US sales of about $230 million.

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