Business Development Opportunities - Pharma Connections Worldwide

REGENERON - Diversified Pipeline can Buffer the Setback

2012-05-15T07:38:26.318Z

Despite the setback in the pipeline – negative recommendation from FDA advisory committee on approval of ARCALYST (R, for prevention of gout flares, PDUFA: July 30, 2012), EYLEA (VEGF Trap-Eye, L in US, partnered with Bayer for Ex-US, wet AMD) remains the key driver for REGN and growth of this franchise should be able to buffer some setbacks in the pipeline. The FDA advisory panel voted 11-0 against approval of the ARCALYST, citing inadequate safety data. REGN’s ex-US partner for Eylea, Bayer entered into co-promotion collaboration with Santen pharma for EYLEA in … For more detail, please read our report, released on May 14, 2012 on REGN, titled “Diversified Pipeline can Buffer the Setback”. REGENERON - Diversified Pipeline can Buffer the Setback

CIPLA - Nothing New – As Expected

2012-05-15T07:37:01.340Z

Cipla’s Q4 FY12 result was below our estimate largely because of lower than estimated sales from Lexapro formulations. EBITDA margin remained flat despite increase in sales from Indore facility and ‘some’ sales from generic Lexapro formulations. This may be due to the continuing ‘rationalization’ of various partnerships in different geographies. Launch of Dymista and Vancomycin by Cipla’s partners in US too may not fetch any meaningful upside in the near term. We reiterate our Market Perform on Cipla but change our target price to `341 as we rollover to FY13 EPS CIPLA - Nothing New – As Expected

CADILA HEALTHCARE - Nearing Inflection Point

2012-05-15T07:34:37.945Z

Cadila’s Q4 FY12 result was much higher than our estimates owing to better performance across the board on sales and margin. Y-o-Y sales grew by 15.3%, EBITDA grew by 20% and net profit declined by 4.5% due to forex loss. FY12 remained a year of consolidation after Cadila acquired Nesher, Bremer and Biochem. Going forward, the company has many earnings triggers like (1) resolution of its facility under warning by the FDA. (2)Improvement in margin from Biochem. (3)Hospira JV. (4)Two new products from Nesher. (5) Possible FTF product launch in FY14. CDH’s focus on technology intensive portfolio for US including transdermals, nasals, injectables too remains lucrative. We upgrade the stock to Outperform with target price of `920. CADILA HEALTHCARE - Nearing Inflection Point

Novartis : Two years safety findings from CATT study favor Lucentis and Eylea, but do pharmacoeconomics justify?

2012-05-05T06:22:56.586Z

The recent two year safety findings from the CATT study in conjunction with the existing evidence from retrospective analysis and the adverse event reporting database of regulators do favor Lucentis and also Eylea in the AMD market, but due to no efficacy difference and pharmacoeconomics weighing heavily against these drugs, we do not see the safety benefits translating into market share gains for either of the drugs. The rate of adverse events at two years, are similar to that observed at the end of first year, which shows that there has been no major increase in adverse events in the Avastin arm after one year. A prominently higher number of GI safety concerns (1.8% vs. 4.8%) and Injury/procedural complications (3.8% vs. 6.0%) primarily distinguish the safety of Lucentis and Avastin, which in our view should not warrant major concerns for ophthalmologists. These safety benefits also need to be validated over the duration of treatment. Novartis : Two years safety findings from CATT study favor Lucentis and Eylea, but do pharmacoeconomics justify?

Ardea Biosciences – “Astra Acquires Ardea – Lesinurad’s Opportunity Expands!”

2012-05-05T05:53:47.160Z

Today’s announcement of an acquisition of Ardea Biosciences (RDEA) by AstraZeneca (AZN) for $32/s or ~$1.26b is the second deal in this month in the gout space, after Takeda (TYO: 4502) acquired privately-held US based, URL pharma. There is a major unmet medical need for a better treatment option for the majority of gout pts, who do not achieve adequate response to allopurinol (serum urate <6mg/dL) and Lesinurad (PhIII, URAT1 Inhibitor) has shown impressive efficacy in its earlier trial. For more details, please read our report released on 23rd April, 2012 on RDEA titled “Astra Acquires Ardea – Lesinurad’s Opportunity Expands”Ardea Biosciences – “Astra Acquires Ardea – Lesinurad’s Opportunity Expands!”

TAKEDA - Azilva in Japan - Differentiating Will Not Be Easy!

2012-05-05T05:52:04.534Z

Takeda is set to launch its me-too ARB Azilva (Azilsartan) in Japan in May-12; Azilva aims to retain revenue of Takeda’s best selling ARB Blopress that is soon going off patent. Takeda highlights the strong hypotensive effects of Azilva and expects to differentiate this drug from other ARB’s to attain ~$800m in 5 years from launch. This report meticulously look into various factors impacting the prospects of Azilva on micro and macro levels viz. evolving competitive landscape, NHI pricing of ARBs and its implications, regulatory and clinical data evaluation and arrives conclusion that Takeda’s hopes from Azilva are too optimistic and difficult to attain.

TAKEDA - Azilva in Japan - Differentiating Will Not Be Easy!

Lupin - Generic Fortamet Launched At Last, However Low Competition Window Shrinks

2012-04-24T06:40:40.327Z

We withdraw our Positive Investment Alert (PIA) on Lupin after it re-launched generic Fortamet ($83m of annual US sales) in the US market. We issued the PIA on 7 Feb 2012 after the Federal Circuit asked the District Court to lift the Preliminary Injunction (PI) on Lupin’s generic Fortamet. While we expected Lupin to launch it soon after the ruling, Lupin waited for the Federal Circuit order putting stay on the Preliminary Injunction that came on 18 April 2012.

The launch still remains ‘at-risk’ as the litigation on patent validity still continues. Earlier we estimated Lupin to generate ~$35m sales from this opportunity, however, this stands limited now.
With the news now discounted in the stock price, we withdraw our Positive Investment Alert on Lupin. Lupin’s launch pipeline Lupin - Generic Fortamet Launched At Last, However Low Competition Window Shrinksin FY 13 includes only one low competition and meaningful product – generic Trico

Hepatitis C Virus Infection: Protease Inhibitors Bring Change in the Treatment Paradigm for Hepatitis C Virus Infection - What Next?

2012-04-20T13:49:02.035Z

HCV focused companies were in limelight last year with major launches, sales data and foremost astounding acquisition premium. The trend in volatility guided by surprises, disappointment is expected to continue this year too. Data presented at European Association for the Study of the Liver (EASL, April 18th – 22nd) this week will trigger the volatility and give food for thought- “was the premium paid justified”?

Vertex, Gilead, Bristol Myers, Abbott, Idenix, Achillion etc are few of the names which will be in the limelight but a look at our detailed report (Protease Inhibitors Bring Change in the Treatment Paradigm for Hepatitis C Virus Infection - What Next?) on HCV details other companies, the attributes of the drugs in pipeline, weakness and strength of the clinical data. Data at EASL and later in the year at American Association for the Study of the Liver Diseases (AASLD) could decide whether INCIVEK (L, Vertex, HCV) life span will be stymied by the “IFN free Options” by 2014 or is the wait going to be longer giving ample time for Vertex to diversify and build value from success in other therapy areas. The likelihood of HCV vaccines in development eradicating the disease or curing it in a more patient friendly way is currently being analyzed and warrants a close watch on the companies developing them…
Hepatitis C Virus Infection: Protease Inhibitors Bring Change in the Treatment Paradigm for Hepatitis C Virus Infection - What Next?

Services for expanding into Russian and CIS markets

2012-03-12T14:27:15.625Z

Professional Consulting Group Co. Ltd provide services only for direct Drug Manufacturers.
Our industry and functional group expertise includes:

•Medicine/Pharmaceuticals/Medical equipment/Biotech/
•Chemical Sector.
•Advertising & Marketing
•Consumer Products
•Human Resources

Solutions:

-Representation and administrative support in Russia and CIS, serving as a contract agent:
◦marketing services; market research;
◦search of potential business partners in Russia
◦looking for clients, dealers, suppliers;
◦distribution;
◦administration services.

With our local presence and international vision, we are able to bridge the cultural and business gaps that often hinder business success in Russia and CIS.

Our team of highly experienced, multi-lingual and multi-disciplined professional staff is able to provide superior services, innovative solutions and technical support in relation to company formation and maintenance, while fully understanding your personal requirements.

Contacts:
Mrs.Mila Galovsky
Business Development Manager
Skype:pcgltd
e-mail: inquiry@proficonsultgroup.com
www.proficonsultgroup.com

Corporate Webcasts: Germany leads in fighting cancer! Ten of Germany's top Life Science companies present...

2012-02-07T18:40:32.289Z

Ten of Germany's top Life Science companies present their science technology and business at this unique Oncology focused forum in Berlin. Members are invited to the free-to-view German Science Day exclusive online broadcasts to learn about the company's science, business and opportunities. Click on the company name to watch the broadcast now.

Presenting Companies

WILEX AG
Prof. Dr. Olaf Wilhelm, CEO
WILEX AG - Research and development of smallmolecule drugs for autoimmune diseases and cancer. The therapeutic agent RENCAREX® (INN: Girentuximab) is a targeted antibody for the treatment of solid tumours.

4SC AG
Dr. Ulrich Dauer, CEO
Resminostat – a novel epigenetic therapy to treat solid cancers in advanced clinical development -- recently met the primary endpoint in a Phase II study in advanced liver cancer.

Evotec AG
Dr. Cord Dohrmann, CSO
Evotec – Partner of choice for oncology drug discovery.

Apogenix GmbH
Dr. Thomas Höger, CEO / CFO
APG101 – A Novel Approach for the Treatment of Cancer. APG101 is a human fusion protein consisting of the extracellular domain of the CD95 receptor fused to the IgG part of an antibody.

Biotest AG
Dr. Christoph Uherek, Head of Preclinical Development
BT-062: A Potent Antibody-Drug Conjugate for the Treatment of CD138 Expressing Tumors.

MorphoSys AG
Dr. Arndt Schottelius, Chief Development Officer
MorphoSys AG (MOR) - developing novel antibodies for therapeutic, diagnostic and research applications. HuCAL technology is one of the most powerful methods available for generating fully human antibodies.

Antisense Pharma GmbH
Dr. Hubert Heinrichs, Acting CEO
TGF-β2 Inhibitor Trabedersen - A promising immunological therapeutic option in aggressive cancers.

Daiichi Sankyo / U3 Pharma
Dr. Philipp Hoffmann, Director Business Development
Daiichi Sankyo/U3 Pharma: development of innovative cancer therapies. A source of several new oncology compounds - most advanced is the U3-1287, a anti-HER3 antibody.

Silence Therapeutics plc
Dr. Klaus Giese, CSO
Pre-Clinical and Clinical Development of Atu027, a Liposomal siRNA, for Therapy in Oncology.

MOLOGEN AG
Prof. Dr. Burghardt Wittig , Chairman of the Scientific Advisory Board.
MOLOGEN AG - Active immune therapies against cancer MGN1703 and MGN1601. MGN1703 is a DNA-based cancer immuno-therapy with an outstanding safety profile.

Assign Group
Dr. Klaus Fischer, CEO
Logistics of Personalized Medicine. Legal framework. Real life case study with an autologous product.