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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Amgen In Focus
Amgen In Focus
Seeking Alpha
According to Amgen, they have 45 drugs in development from Phase 1 to Phase 3. Conversely, Gilead has 32 drugs in development and Pfizer has 64. Meanwhile, Gilead only has 8 drugs in Phase 3, Pfizer has 25, and Amgen has 14. 7 of those Phase 3 …
http://seekingalpha.com/article/1510002-amgen-in-focus?source=google_news
Amgen has the second deepest pipeline of drugs of the three large cap biotechs. According to Amgen, they have 45 drugs in development from Phase 1 to Phase 3. Conversely, Gilead has 32 drugs in development and Pfizer has 64. Meanwhile, Gilead only has 8 drugs in Phase 3, Pfizer has 25, and Amgen has 14. 7 of those Phase 3 drugs are focused on cancer treatments for Amgen, more than either Pfizer or Gilead. Keep in mind that 12.4 million people learn they have cancer each year, while 7.6 million people lose that battle each year. The CDC predicts that the global number of cancer related deaths will increase by 80% by 2030. It doesn’t take a rocket scientist to know that cancer treating drugs presents the largest opportunity for any drug maker considering those statistics. Amgen has the inside track versus Gilead and Pfizer as far as quantity of drugs in late stage development.
Modality
Generic Licensing News –NAPHAZOLINE NITRATE, featured product
NAPHOZALINE
PRODUCT USED AS
NAPHAZOLINE NITRATE
Naphazoline Nitrate is a rapid acting sympathomimetic vasoconstrictor of occular artierioles. It acts to decrease congestion of the conjunctiva and is found in many over-the-counter eye drops.
Naphazoline is primarily indicated in conditions like Corneal vascularity, Hyperaemia, Itching, Nasal congestion, and can also be given in adjunctive therapy as an alternative drug of choice in Sinusitis.
http://www.leadformix.com/ef1/preview_campaign.php?lf1=933470130c201312625317b456273
Click here to contact Farmak about this product.
more info
It is a sympathomimetic agent with marked alpha adrenergicactivity. It is a vasoconstrictor with a rapid action in reducing swelling when applied tomucous membrane. It acts on alpha-receptors in the arterioles of the conjunctiva to produce constriction, resulting in decreased congestion. It is an active ingredient in several over-the-counter formulations including Clear Eyes and Naphcon eye drops.
Naphazoline, 2-(1-naphthylmethyl)-2-imidazoline, is synthesized from (1-naphthyl)acetonitrile, which upon reaction with ethanol transforms into iminoester, and undergoes further heterocyclization into the desired imidazoline derivative upon reaction with ethylene diamine 
- A. Sonn, U.S. Patent 2,161,938 (1939).
company-Turkey Abdi Ibrahim Ilac San.Tic. A.S
Abdi Ibrahim Ilac San.Tic. A.S
Abdi İbrahim started out as a pharmacy in the neighbourhood of Küçükmustafapaşa about 100 years ago. Since 2003, however, it has been the leading company in the Turkish pharmaceuticals markets, operating out of its factory, which was opened in 1919 in Mahmutpaşa with the name Abdi İbrahim Müstahzarat-ı İspençiyariye.
Abdi İbrahim is the first Turkish company to make the list of the top 100 pharmaceutical companies in the world.
READ AT
http://genericlicensing.com/abdi_ibrahim_4/company.html?lf1=848454812f907212625317c7279334
Quizartinib — a Phase 2B trial treatment for acute myeloid leukemia
quizartinib
Ambit Biosciences
Ambit Biosciences (NASDAQ:AMBI) is a biotech company that focuses on treatments that inhibit kinases, which are drivers for diseases such as cancer. Three drugs are in development, with the lead one being quizartinib — a Phase 2B trial treatment for acute myeloid leukemia.
However, AMBI’s collaboration agreement with Astellas Pharma (OTC:ALPMY) is set to expire in September, and if it is not replaced, it could mean a delay in Phase 3 trials for quizartinib. Keep in mind that AMBI generated $23.8 million in collaboration revenues last year.
Quizartinib (AC220) is a small molecule receptor tyrosine kinase inhibitor that is currently under development for the treatment of acute myeloid leukaemia. Its molecular target isFLT3, also known as CD135 which is a proto-oncogene.[1]
Flt3 mutations are among the most common mutations in acute myeloid leukaemia due tointernal tandem duplication of Flt3. The presence of this mutation is a marker of adverse outcome.
Specifically, Quizartinib selectively inhibits class III receptor tyrosine kinases, including FMS-related tyrosine kinase 3 (FLT3/STK1), colony-stimulating factor 1 receptor (CSF1R/FMS), stem cell factor receptor (SCFR/KIT), and platelet derived growth factor receptors (PDGFRs).Mutations cause constitutive action of Flt3 leading to resulting in inhibition of ligand-independent leukemic cell proliferation and apoptosis
It had good results in a phase II clinical trial for refractory AML – particularly in patients who went on to have a stem cell transplant.[2]
- Chao, Qi; Sprankle, Kelly G.; Grotzfeld, Robert M.; Lai, Andiliy G.; Carter, Todd A.; Velasco, Anne Marie; Gunawardane, Ruwanthi N.; Cramer, Merryl D.; Gardner, Michael F.; James, Joyce; Zarrinkar, Patrick P.; Patel, Hitesh K.; Bhagwat, Shripad S. (2009). “Identification of N-(5-tert-Butyl-isoxazol-3-yl)-N’-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea Dihydrochloride (AC220), a Uniquely Potent, Selective, and Efficacious FMS-Like Tyrosine Kinase-3 (FLT3) Inhibitor”. Journal of Medicinal Chemistry 52 (23): 7808–7816.
- Drug Tames Refractory AML. ASH Dec 2012
Hutchison Chi-Med in Partner Talks for Cancer Drug
WO-2011060746 Compound, certain novel forms thereof, pharmaceutical compositions thereof and methods for preparation and use
may give you the structure
May 9, 2013
Hutchison Chi-Med expects to license global rights to fruqintinib, one of its novel small-cell cancer drugs, before year-end, according to CEO Christian Hogg.
The company has been in due diligence discussions with potential partners, he added. Because the drug is a promising treatment for solid tumors,
Chi-Med will conduct simultaneous clinical trials against several types of cancer, and the company wants a partner to help shoulder the financial burden
Hutchison China MediTech Ltd. (HCM), the drugmaker controlled by Hong Kong billionaire Li Ka-shing, is in talks to license a cancer treatment based on traditional Chinese medicines, Chief Executive Officer Christian Hogg said.
The Hong Kong-based company, known as Chi-Med, completed due diligence with potential partners and will probably reach an agreement on fruquintinib by year-end, Hogg said yesterday in an interview in London, where the shares trade. The medicine may be used to treat colorectal, lung, breast and gastric cancers, he said.
“A deal on fruquintinib is a pretty important priority,” Hogg said. “What we want to do is partner and take on in parallel clinical programs in all of those tumor types.”
A licensing agreement on fruquintinib, which has completed early-stage testing, would follow a joint venture with Nestle SA (NESN), which last month said it has started late-stage trials of HMPL-004 for ulcerative colitis. Chi-Med is aiming to be the first drugmaker to bring to market pharmaceutical products from traditional Chinese botanicals.
Fruquintinib will probably be the last product for which Chi-Med will grant global marketing rights to a partner, with subsequent agreements giving Chi-Med the rights to China, Hogg said. China’s pharmaceutical market is expected to grow as much as 18 percent a year to $165 billion by 2016, making it the world’s second-largest market after the U.S., according to consultancy IMS Health Inc.
TMC310911, Ascletis In-Licenses China Rights to HIV Drug from Janssen
TMC310911, credit pubchem
see structure http://aac.asm.org/content/55/12/5723/F1.expansion.html
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232804/ structure available
TMC310911, Ascletis In-Licenses China Rights to HIV Drug from Janssen
Apr 30, 2013
Ascletis, a China-US drug developer, has in-licensed China rights to a next-generation HIV protease inhibitor from Janssen R&D Ireland, a subsidiary of Johnson & Johnson. Janssen believes the drug, known as TMC310911, is likely to prove more effective against drug-resistant strains of HIV than currently available PIs. The molecule is the third drug candidate in-licensed by Ascletis, which is also developing its own siRNA anti-cancer drug candidate.
Merck & Co and Pfizer join forces on diabetes pill
ertugliflozin
PF04971729
(1S,2S,3S,4R,5S)-5-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol
Drug giants Merck & Co and Pfizer have formed a new alliance to jointly develop and commercialise the latter’s ertugliflozin for the treatment of type II diabetes.
The drug is an investigational oral sodium glucose cotransporter (SGLT2) inhibitor, which is on the verge of entering Phase III trials, scheduled for later this year.
read more
http://www.pharmatimes.com/Article/13-04-30/Merck_Co_and_Pfizer_join_forces_on_diabetes_pill.aspx
CHINA MARKET-Takeda and Sanofi Sign Co-promotion Agreement to Expand Reach of Diabetes Treatment Alogliptin in China
ALOGLIPTIN
22.04.2013
• Alogliptin is a DPP-4 inhibitor that is designed to slow the inactivation of incretin hormones GLP-1 and GIP
• Agreement is part of Takeda’s strategy to complement capabilities through partnerships
• Agreement complements Sanofi’s diabetes portfolio and expand its offer of innovative diabetes treatment to Chinese patients
• The regulatory approval of alogliptin in China is expected in 2013
Shanghai, China, April 22, 2013 – Takeda and Sanofi today announced that they have entered into an agreement for the co-promotion of alogliptin in China for the treatment of type 2 diabetes. Alogliptin is Takeda’s new type 2 diabetes therapy, which has been filed for marketing authorization in China. It is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).
Under the terms of the agreement, Takeda will grant Sanofi the exclusive right to co-promote alogliptin in China. Sanofi will utilize its commercial capabilities and experience to promote the product in defined territories in China. The commercial terms of the agreement were not disclosed.
“Diabetes has become a major public health problem in China with a rapid increase in the prevalence over recent years. China is now the country with the largest number of people with diabetes,” said Haruhiko Hirate, Corporate Officer and Head of North Asia of Takeda. “The collaboration will expand our reach to Chinese physicians treating patients with type 2 diabetes. Both Takeda and Sanofi have a long history and significant experience in diabetes and this makes for a win-win partnership, as we work together to advance patient care and help to meet the needs of this growing patient population.”
“We are pleased to announce the collaboration with Takeda,” said Fabrice Baschiera, General Manager, Pharmaceutical Operations, Sanofi China. “Alogliptin reinforces the strategic focus of Sanofi in the diabetes field. The new addition of alogliptin strengthens our offer of innovative diabetes treatment to Chinese patients, which includes best-in-class oral and insulin drugs. We look forward to working with Takeda to make alogliptin more widely available to patients with type 2 diabetes in China,” added Mr. Baschiera.
Alogliptin was approved and marketed in Japan in 2010 under the brand name of Nesina®, where it is currently the best-selling DPP-4i for type 2 diabetes. It was approved by the U.S. FDA as a monotherapy and also in fixed-dose combination with pioglitazone (Oseni®) and metformin (Kazano®) in January 2013 for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
In China, the rapid economic development has brought mass urbanization, changing diets and increasingly sedentary lifestyles. These factors greatly increase the risk of developing type 2 diabetes. China has the largest number of people with diabetes1, with approximately 92.4 million adults suffering from the disease, 60.7% of which are undiagnosed2. Over the next 20 years, an additional 40 million Chinese adults are expected to develop type 2 diabetes, surpassing the overall prevalence rate of the United States3.
Alogliptin is under registration review in China. Takeda is expecting to obtain the regulatory approval in 2013.
Notes
1 International Diabetes Federation. New diabetes figures in China: IDF press statement
2 Diabetes: Wenying Yang et al, N ENGL J MED, March 25, 2010;
3 Kantar Health. The Burden of the Complicated Type 2 Diabetes Patient in China.
About Alogliptin
Alogliptin is a DPP-4i for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4 is designed to slow the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application (NDA) for NESINA (alogliptin) was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is available under the same brand name in Japan. NESINA (alogliptin) was approved by the U.S. FDA as a monotherapy and also in fixed-dose combination with pioglitazone (OSENI) and metformin (KAZANO) in January 2013 for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes affecting millions of people globally. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help them manage their blood glucose levels. According to the International Diabetes Federation, the global health care expenditures for diabetes (both type 1 and 2) were estimated at $471.6 billion in 2012. By 2030, this number is projected to exceed $595 billion. China is now the country with the largest number of people with diabetes and 92.4 million adults are suffering from the disease.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website,www.takeda.com.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
From a structural point has uracil (Uracil) structure, synthesis of these compounds are usually replaced with urea or urea and 1,3 – parents Electric reagent directly related ring, and substituted ureas from amines and isocyanate obtained. Compound 1 and methyl isocyanate urea derivatives obtained by reacting 2 , 2 and 1,3 – diethyl reaction 3 , 3 chlorination with phosphorus oxychloride to obtain 4 , 4 with a secondary amine 5 reaction of 6 , 6 de-Boc protected with acid reaction and generate benzoate Alogliptin benzoate.
AstraZeneca inks cancer deals with Bind and Horizon
AstraZeneca has signed a nanomedicines pact with Bind Therapeutics in a deal which could be worth $200 million to the privately-held US biopharma firm.
The firms will work together to develop what Bind calls an “Accurin”, a targeted and programmable cancer nanomedicine, based on a kinase inhibitor owned by the Anglo-Swedish drugmaker……………………..READ MORE AT PHARMATIMES
http://www.pharmatimes.com/Article/13-04-22/AstraZeneca_inks_cancer_deals_with_Bind_and_Horizon.aspx
New Drug Approvals 