NCE + Marketing agreement Ranbaxy Launches a New Chemical Entity (NCE), Lulifin (Luliconazole) in India

Source Press Release

Company Ranbaxy Laboratories, Nihon Nohyaku, Summit Pharmaceuticals International (SPI) Tags Date Systemic Anti-Infectives, Launches January 04, 2010

The Dermatological Product In-licensed from Summit Pharmaceuticals, Japan, Strengthens Ranbaxys Skin Portfolio

Gurgaon, India -- January 4, 2010 -- Ranbaxy Laboratories Limited (Ranbaxy) announced today that the Company has launched a New Chemical Entity (NCE), Lulifin (Luliconazole), in the Indian Dermatology market. This follows a strategic in-licensing agreement with Summit Pharmaceuticals International Corporation, Japan (SPI) allowing Ranbaxy, exclusive marketing rights, for India. The introduction of this NCE, significantly strengthens Ranbaxys presence in the Dermatological segment.

Commenting on the development, Mr. Sanjeev Dani, Sr. Vice President & Regional Director Asia, CIS & Africa, Ranbaxy, said, It is well recognized that in the post patent era, licensing would be the key strategy to bring New Chemical Entities to India. Dermatology is one of the top priority therapeutic areas for us and we are pleased to introduce Lulifin in the Indian market. We would be manufacturing the product in India under licence from SPI, Japan.

Luliconazole was discovered by Nihon Nohyaku Co. Ltd. (Nihon Nohyaku) and was approved and launched in Japan in 2005. Based on SPIs licensing know-how and strong network abroad, SPI in-licensed the rights for Luliconazole in certain territories from Nihon Nohyaku, to expand its reach in overseas markets. In India, SPI has entered into a licensing agreement with Ranbaxy to market the product exclusively.

Lulifin is a topical imidazole and is indicated for Cutaneous mycoses caused by Tinea pedis, Tinea corporis, Tinea cruris. Currently, topical imidazoles and allylamines are used for the treatment of Cutaneous mycoses with disadvantages like long duration of therapy, which leads to poor compliance and a high relapse rate. Clinical trials conducted by Nihon Nohyaku with Pola Chemical Industries, Inc. (currently Pola Pharma Inc. Tokyo), in Japan and by Ranbaxy, in India, confirm the at par efficacy with other topical imidazoles but with the added advantage of shorter

therapy duration and once a day application. This greatly improves patient compliance with significantly better outcomes.

Ranbaxy already has a strong presence in the Dermatology market with products such as Zole-F, Minoz, Suncros, Fucidin and Teczine, among others.

SPI is a 100% daughter subsidiary company of Sumitomo Corporation (SC) and is an integrated service company specializing in the area of pharmaceutical research and development. SPI has a good track record in activities such as, exclusive agent of ATCC (the worlds largest gene/cell bank for research) of the USA, support of discovery research through distribution/sales of compound libraries for HTS (High Throughput Screening high-speed technology for early drug candidate compounds selection in discovery research), supply of starting materials, intermediates and bulk drug substances for pharmaceuticals, and intermediation/consultation services in license/coresearch arrangements of promising drugs/diagnostics/technologies originating from domestic and foreign bioventures, pharmaceutical companies, universities and institutes.

Nihon Nohyaku Co. Ltd is an agrochemical company listed on the Tokyo Stock exchange and has been working to revolutionize technology in its core area of business involving manufacture and sale of safe and superior agrochemicals. Furthermore, working from the basis of agrochemical research, development and manufacturing, Nihon Nohyaku have been expanding the business in fields such as chemical products, pharmaceuticals, animal health products, and organic intermediates.

New Chemical Entities: The Challenge continues

Mar 15, 2007 Manisha Singh Nair What is the extent of patentability?

page 1 of 1
India became party to TRIPS Agreement in the year 1994, and TRIPS through Article 27 of TRIPS mandated the member countries to provide patents for inventions in product or process in all fields of technology. India, at that point of time was not awarding product patent to medicine or drugs. As a developing country, India gained all together ten years to comply fully with TRIPS. A series of amendments followed, the latest in 2005, brought about a paradigm shift in the Patents Act by deleting Section 5, thereby opening up product patent

regime in medicines or drugs. Ironically all the amendments in the Patents Act have been introduced through Ordinances, as the Parliament at that point of time was not in session. Primarily, the controversy revolved around the decision to award product patent, and as the cloud was settling a new controversy emerged concerning the extent of patentablity. Section 3 (d) would be the most controversial provision introduced by the latest amendment, as the constitutional validity of the provision itself has been challenged by Novartis Pharmaceutical company in Chennai High Court. On analysis it is seen that the controversy was attached with the provision even from its prelude stage. The main allegation that was leveled against the provision in the Ordinance was that the word mere new use would open up the concept of Swiss Claims, which in effect would lead to ever greening of patents. Taking into consideration the uproar, the prefix mere was dropped from the Amendment Act and a reframed new section 3 (d) was figured in the Amendment Act of 2005. But in truth, not only that the section could arrest the controversy, rather it generated controversy. The Left parties, in the Parliament had differed and were not satisfied with certain changes, and hence the Government assured the Parliament to refer the matter to an expert group under the Chairmanship of Dr. Mashelkar to decide on 1. whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; and 2. whether it would be TRIPS compatible to exclude micro-organisms from patenting. On parallel tracks Indian patent law was witnessing another development. Gleevec - a cancer drug by Novartis AG, a Swiss pharmaceutical company, was rejected the grant of patent. Aggrieved by the order, Novartis filed two batches of writ petition challenging the validity of the section and the order of the Registrar, before the Chennai High Court. One of the main contentions of Novartis is that the section is unconstitutional as the provision is against the mandate of TRIPS and had completely ignored the rationale underlying Article 253 and 51 (a) of the Constitution. The section further attracted attention as the Expert Committee laid its report. The Expert Committee had concluded that excluding non NMC from patentablity was not in tune with TRIPS mandate. In other words, Section 3 (d) does not adhere to TRIPS and further that any attempt to exclude microorganisms per se from patent protection would be violative of TRIPS. Novartis had placed on record the findings of the report to substantiate their claim. But the Report was subsequently taken back due to allegation of plagarism in certain dailies. The Report eventhough not binding on the Court, had persuasive value. But, the withdrawal have extinguished the persuasive value the Report had. An interesting development in the ongoing litigation is that Novartis had made an application to convert one of the writ into regular appeal which was strongly opposed by the Government, Indian Generic Manufacturers and Indian Pharmaceutical Alliance, but the application was allowed and it is reported that the a writ has been converted into regular appeal. Earlier, the High Court had accepted the application of Indian Generic Manufacturers and Indian Pharmaceutical Alliance, but the application was allowed and it is reported that the a writ has been converted into regular appeal. Earlier, the High Court had accepted the application of Indian Generic Manufacturers and Indian Pharmaceutical Alliance to array them as parties to the on going litigation.

The State along with other organizations argue that the TRIPS itself provides flexibilities and permit member countries to formulate their own laws and regulations. They further argue that the section is fully TRIPS compliant as it fulfilled the objective of discouraging patent applications for substance that were not new, but enabled patenting of genuine innovations. At this juncture it is pertinent to point out that the Expert Committee had asked for a period of three months time to resubmit the report for which the Governments' stand is yet to be known, all the while the Chennai High Court is witnessing one of the vital case which could determine the future of Indian Patent law. Precisely, at present patent is the sizzling topic in India

Now, a synthetic anti-malaria drug

Kounteya Sinha, TNN Apr 24, 2012, 01.21AM IST

Tags:

Vietnam| Union health minister Ghulam Nabi Azad| The National| synthetic anti-malaria drug| Ranbaxy| malaria| Ghulam Nabi Azad| East Africa| Artemisinin| Africa

NEW DELHI: India has developed a powerful new malaria drug - an alternative to the global drug of choice Artemisinin - that promises to be a major boost to India's pharmaceutical research. What is most exciting about this new drug is that its raw materiel is synthetic (derived chemically in the lab) as against Artemisinin, which is derived from a plant.

Ads by Google

Product SuppliersConnect with over 120,000 suppliers from Hong Kong, China and
Taiwanwww.hktdc.com

Get 50Lac after 15Years*Invest

PlanPolicyBazaar.com/Investment-Plans

LIC

3600 p.m

Union health minister Ghulam Nabi Azad and Ranbaxy will unveil India's first new chemical entity (NCE) against the P falciparum malaria on Wednesday to commemorate the World Malaria Day.

Dr Neena Valecha from the National Institute of Malaria Research (NIMR) said this new once-a-day therapy for three days contains Arterolane and Piperaquine. "Clinical trials conducted by NIMR comparing the Arterolane and Piperaquine combination has shown it to be as effective and as safe as artemisinin combinations like Artesunate and Sulphadoxine which is used in the national malaria programme," said Dr Valecha, who was the principal investigator of the trials. Artemisinin derivatives are most rapid acting and effective anti-malarial medicines, according to her. Artemisinin is the only high-volume drug that continues to be produced from a plantbased source. China and Vietnam provide 70% and East Africa 20% of the raw material. Seedlings are grown in nurseries and then transplanted into fields. It takes about eight months for them to attain full size. The plants are harvested, leaves dried and sent to facilities where artemisinin is extracted. The market price for artemisinin has fluctuated widely, between $120 and $1,200 per kg from 2005 to 2008. "However, they are plant derived and, therefore, there can be mismatch in demand and supply. It is used in combination with different drugs (artemisinin-based combination therapy). Now, five combinations are recommended by WHO. On the other hand, since this new drug is synthetic, its raw materials are created chemically in the lab. This will ensure constant supply of raw materiel and standardize costs," added Dr Valecha. Arterolane in combination with long acting piperaquine has been studied in phase II and III clinical trials in India, Bangladesh and Thailand. Most malaria parasites have become resistant to anti-malarial drugs. To protect artemisinin from developing resistance, it is recommended that it should only be used in combination with partners and oral artemisinin should never be used as monotherapy. The Drugs Controller General of India has imposed a ban on use of oral artemisinin monotherapy for uncomplicated falciparum malaria. Artemisinin resistance is characterized by slow parasite clearance. Artemisinin Combination Therapies (ACT) kills malaria parasite in a human bloodstream within 2436 hours. With the drug-resistant strain, ACT needs up to 120 hours to kill the parasite. India records 1.5 million cases of malaria every year, 50% of which are caused by the falciparum malaria. Officially, an estimated 18,000 die of malaria in the country. "Combination therapy is a deliberate strategy to delay the development of drug resistance. ACTs deliver a two-punch attack on the malaria parasite. By combining drugs with different mechanisms of action and different time spans of activity, ACTs increase the likelihood that any parasites not killed by one drug will be killed by the

second one. The usefulness of these therapies is now under threat," said WHO director general Margaret Chan.
Ads by Google

View 20 Lacs + TendersIndia's National Tender Portal Call 09824051600 / 09374530073www.TenderTiger.com Garden City CollgeAffiliated to BU,Approved by AICTE Govt. of India, Accredited by NAACwww.gardencitycollege.edu

Every year, 250 million cases of malaria infections are reported around the world, causing nearly one million deaths. According to the recent World Malaria report, 2011, over 70% of India's population, or 100.41 crore face the risk of malaria infection. Around 31 crore, however, face the "highest risk" of getting infected by the vector-borne disease. WHO said India has over 10 crore suspected malaria cases, but only 15.9 lakh could be confirmed last year. Of the confirmed cases, 8.3 lakh people were infected by plasmodium falciparum, while 7.6 lakh were infected with Plasmodium Vivax. Malaria mortality rates have fallen by more than 25% globally. The number of malaria cases in India has dropped from two million a year to 1.5 million in recent years, but the percentage of the more dangerous form of the disease, P falciparum infection, has increased in some areas.

Kicking back to life

TNN May 16, 2005, 12.42am IST

After a dull patch Indian pharmaceutical companies are back in action with a spate of acquisitions and out-licencing deals. TASC Pharmaceuticals, which recently amalgamated Glenmark Laboratories with itself to have a presence in pharmaceuticals and bio-pharmaceuticals, is readying for an entry into the US market. The company is looking for acquisition of a US-based pharmaceutical company with a marketing set up and basket of ANDAs. The target company could have a size of $50m. This will allow TASC to make inroads into the lucrative US generics market.

Ads by Google

Top 20 Pharma CompaniesAnnual report on the biggest names in small

molecules.www.contractpharma.com Product SuppliersConnect with over 120,000 suppliers from Hong Kong, China and Taiwanwww.hktdc.com
TASC is also developing a new chemical entity (NCE) called RISUG and has worldwide patent for it. RISUG is an injectible contraceptive with potential markets in developing and developed countries. The company is in the process of out licensing this molecule to an MNC pharma company. The company is entering into in-licensing agreement with a US MNC for exclusive marketing rights in India for its patented products.

Piramal Healthcare stock plunges on realty plan

May 10, 2011, 05.27am IST

Tags:

Piramal Life Sciences| Piramal Healthcare Ltd.| Macquarie Securities| Indiareit Fund| Aberdeen Asset Management| Abbot Laboratories

MUMBAI: Piramal Healthcare plunged the most in a year as investors frowned at the drugmaker's plan to begin lending for infrastructure and real estate, instead of expanding pharma business or sharing the cash pile with shareholders. The stock, owned by investors such as Aberdeen Asset Management and Fidelity, crashed 9% to Rs 417.55. "Given the uncertainty regarding the use of cash for risky ventures, we believe there will be pressure on the stock and that clarity is unlikely in the medium term" said analysts at Macquarie Securities in a report downgrading the stock to Underperform and cutting price target to Rs 370, from Rs 600.

Ads by Google

Long Term Stock PicksFree Guide - How To Identify Long Term Multibagger Stock
Picks.Equitymaster.com/Free_Stocks_Guide Custom SynthesisConduct pharma research efficiently and competitively.www.svchembiotech.com
The drugmaker led by Ajay Piramal sold its domestic formulations business to Abbot Laboratories for 17,000 crore. Although, the company paid a special dividend, it was tiny compared to the money it

received. Investors believe that the company would have done better if it had let them decide what they do with the cash, instead of the promoters investing in a finance company. The company had on Friday after market hours announced that it would enter financial services business by setting up an NBFC for lending in real estate and infrastructure sectors. It also announced acquisition of IndiaReit Fund Advisors and IndiaReit Investment Managers for an aggregate of Rs 225 crore. The board of Piramal Life Sciences also approved demerger of its new chemical entity (NCE) to Piramal Healthcare and said shareholders of Piramal Life will get one share of the healthcare firm for every four held.

Piramal Life may unveil new chemical entity by 2011

Nina Mehta, ET Bureau Feb 11, 2009, 12.12am IST

MUMBAI: Piramal Life Sciences, the listed research and development (R&D) subsidiary of Piramal Healthcare, is hoping to hit the market with its first New Chemical Entity (NCE) by 2011. The company is currently developing drugs in oncology, diabetes, inflammation disorders and anti-infectives. Piramal Life Sciences was hived off as a separate entity in May 2008. This was done to segregate research from the company's contract manufacturing and generic businesses. "We have received encouraging results from our molecules, which are in various phases of clinical trials. The molecule (P276) for head and neck cancer, mantle cell lymphoma, malignant melanoma and multiple myeloma is in three phase II clinical trials and one phase I/II clinical trial in India, the US and Australia. There is no drugs which treat head and neck cancer with minimum side-effects and our aim is to tap this market worldwide," Somesh Sharma, managing director of Piramal Life Sciences told ET.

Ads by Google

Upload Your ResumeSubmit Resume Now & Get Access To Latest Jobs in Infosys. Apply
Now!www.shine.com/Infosys_Jobs

Unmissable Pharma NewsLeading Pharma, Biotech & Generics Industry news

comment and analysiswww.thepharmaletter.com
Piramal Healthcare is one of the largest custom manufacturing companies in India with a global footprint of assets across North America, Europe and Asia. It operates two divisions, healthcare solutions and pharma solutions. The pharmaceutical market for head and neck cancer is estimated at $400 million a year with no treatments other than chemotherapy and radiation. It is the sixth most common cause of cancer worldwide, affecting approximately six lakh people a year. NPB 00105, another cancer drug from their stable, is in phase I/II clinical trials for Gleevac resistant chronic myeloid leukaemia.

"We hope to be financial viable by 2010 at the earliest or by 2011. Currently, all our funding comes from the parent company as well as the collaborations that we have," said Mr Sharma. The company has longterm collaborations with US-based Merck & Co to develop oncology-based drugs. They are identifying the molecules and will enter phase I clinical trails by end-2009. The company is currently collaborating with Eli Lilly in the area of diabetes and metabolic disorders. "P1201, a compound from our collaboration with Lilly, is about to complete phase 1 studies, while P 2202, also a compound from Lilly collaboration, is in phase 1 studies in Canada. P1736, a non PPAR insulin sensitise, has completed phase 1 studies in Europe," said Mr Sharma. Analysts say that the company could tap a huge market for type 2 diabetic treatment and P1736 will hit the market soon. Industry experts estimate that the Indian type 2 diabetes drug market will double from $504 million in 2007 to more than $1.1 billion by 2012.

Ranbaxy in pact with Schwarz

TNN Jun 27, 2002, 10.17pm IST

NEW DELHI: Domestic pharma major Ranbaxy Laboratories on Thursday announced its licensing deal with Schwarz Pharma AG for development of its new chemical entity RBx 2258 for the treatment of benign prostate hyperplasia. In a statement, the company said the licensing deal would allow Schwarz to obtain exclusive rights for marketing, development and distribution of the product in Europe, Japan and the United States, while Ranbaxy would retain the rights for other markets.

Ads by Google

Ankylosing SpondylitisYou need Life Force homeopathy for Better control, relief,
managementAnkylosingSpondylitisCure.com What You Need to KnowUnbiased news for the pharmaceutical industry.www.ThePinkSheetDaily.com
ET has reported on June 19 Ranbaxy and Schwarz finalising the deal on the licensing agreement on RBx 2258. The agreement would entail payment of $42 million by Schwarz to Ranbaxy over next five to six years including an upfront payment of $6.3 million to be followed by royalty payments upon commercialisation. The agreement also provides for Ranbaxy to manufacture and supply finished formulations of the product to Schwarz Pharma. The deal is, however, subject to Reserve Bank of India approval. The new drug aims to develop once a day formulation to provide rapid relief, low incidence of side effects and good compliance.

"We welcome the new opportunity to develop a new compound to treat BPH and to collaborate with Ranbaxy which has an established reputation for its high standards of ethics and quality", Chief Executive Officer Schwarz Pharma AG Patrick Schwarz-Schutte said. Worlwide market for BPH is placed at $2.2 billion with more then 51 million men aged over 40 suffering from the disease in Europe, USA and Japan. Ranbaxy's RBx is currently undergoing clinical Phase II trials in India.