While the focus of activity in pharmaceutical R&D has shifted from mass-market primary care drugs to specialty products, there are signs the long freeze on big new medications is thawing. In recent months, a slew of potentially significant new drugs have been approved, including Pfizer’s Chantix, Exubera and Sutent, BMS’s Sprycel and Merck’s Gardasil, among others, and there are many more potentially significant products waiting in the wings.

1. Torcetrapib/Atorvastatin Pfizer
Torcetrapib could be the drug that rescues Pfizer’s cholesterol franchise when Lipitor, scheduled to lose patient protection in 2010, goes generic. Pfizer plans to market the drug, which raises good cholesterol, in combination with Lipitor. The drug does have a worrisome side effect—increased blood pressure—and questions remain over its efficacy at reducing arterial plaque as compared with Lipitor alone. Torcetrapib is currently in Phase III clinical trials and an NDA is expected to be filed next year. “If it works, if it reduces events significantly and the blood pressure effects are not to pronounced, it could have a huge impact,” says Deutsche Bank pharmaceutical market analyst.  

2. Prasugrel Eli Lilly & Co./Sankyo
The platelet inhibitor is in head-to-head studies against BMS/Sanofi Aventis’ Plavix (clopidogrel), a global blockbuster five times over. Early signs are that the drug, in Phase III clinical trials and expected to file in 2007, does a better job of preventing platelet accumulation than Plavix. From a commercial perspective, however, the fate of prasugrel, as well as that of an AstraZeneca antiplatelet in development, also hinges on the launch of a generic version by Canadian generics firm Apotex in August. But regardless of the outcome of Plavix litigation, prasugrel could tap a massive market if proven significantly better than Plavix at reducing cardiovascular events in at-risk patients. 

3. Januvia Merck
Merck is looking to succeed in Type 2 diabetes where others—AstraZeneca (tesaglitazar), BMS (muraglitazar) and Takeda (sipoglitazar)—have failed. Merck’s DPP-IV inhibitor, already approved in Mexico, has made it to late Phase III clinical trials without exhibiting the dangerous cardiovascular side effects that shuttered work on its rivals. Even so, it could face competition from Novartis’ Galvus (vildagliptin), as well as Pfizer’s Exubera and Lilly/ Amylin’s Byetta. But should Januvia realize the great hope of the glitazars, fighting dyslipidemia and hyperglycemia, it could make a big splash in the US market for diabetes drugs, estimated to be worth as much as $17 billion by 2011.

4. MK-524B Merck
Another cardio combo. The drug, which combines simvastatin with a novel compound said to lower bad cholesterol and triglycerides while raising good cholesterol, could prove a new lease on life for Zocor, which lost patent protection in June. Phase II data will be submitted to the American Heart Association meeting later in the fall. Zocor boasted $4.4 billion in US sales last year. With generic Zocor on the market, managed care organizations exerting more influence and a potential competitor in Pfizer’s torcetrapib, it would be tough for Merck to recoup its losses if the drug does ace its Phase III clinical trials.     

5. Acomplia Sanofi-Aventis
If obesity drug Acomplia makes it to market—and it’s still an “if”—it will almost certainly boast the biggest brand awareness at launch since Viagra. Sanofi-Aventis’ biggest challenge could be living up to the hype. But first the drug, having passed muster with Europe, must win over the FDA, which has already scotched an indication for smoking cessation. Analysts estimate the drug could be worth as much as $3 billion in the US, but with prices above $100 for a month’s supply in the UK and Germany, it will require a huge marketing push to get it there.

6. DVS-233/Desvenlafaxine Wyeth
FDA delayed the decision on this Effexor XR follow-on until January.

7. Cervarix GlaxoSmithKline
GSK is chasing Merck’s HPV vaccine Gardasil. The firm says the drug could bring a 76% reduction in cervical cancer deaths.

8. VX-950 (HCV) Vertex/Janssen
Vertex is pairing with J&J’s Janssen to develop and co-market this hepatitis C protease inhibitor.

9. Bazedoxifene Wyeth
Wyeth’s SERM for postmenopausal osteoporosis could come to market by 2008.

10. Galvus Novartis
Novartis’ glitazar for Type II diabetes is racing Merck’s Januvia to market.

11. Panitumumab Amgen/Abgenix
This colorectal cancer drug could threaten ImClone’s Erbitux franchise and is also being tested for head and neck cancers.

12. Rasilez Novartis
Novartis recently presented encouraging data on this blood pressure drug, which is already submitted in the US, and is due to be submitted in Europe this year.

13. CERA Roche
Having triumphed in a patent dispute with Amgen, Roche is seeking US approval for this renal anemia drug, which could compete with Amgen’s Epogen and Aranesp.

14. Vicriviroc Schering-Plough
The investigational CCR5 receptor antagonist (HIV) has shown promise for reducing viral loads in Phase II clinical trials.

15. Centryx Traficet-EN GlaxoSmithKline/Chemo
The compound, considered a leading contender in the promising chemokine class to treat Chron’s Disease, has attracted the interest of GSK.

16. TAK-390MR TAP
This proton pump inhibitor acid-reflux drug, a follow-on to Prevacid, is in Phase III clinical trials.

17. PRO-1762 (AKA APO2L/Trial) Amgen/Immunex/Genentech
A potential cancer therapeutic for a variety of solid tumors and hematologic malignancies in early development.

18. Actemra Roche
This rheumatoid arthritis drug has shown promise at inhibiting the progression of joint destruction in Phase III clinical trials.

19. Maraviroc Pfizer
Pfizer says it will file with FDA for its CCR5 entry inhibitor for HIV later this year.

20. Javlor BMS/Pierre Fabre
The drug, in Phase III clinical trials in Europe for bladder and non-small cell lung cancer and Phase II trials for breast and ovarian cancer, drew the interest of BMS.

21. Bifeprunox Solvay/Lundbeck/Wyeth
The atypical antipsychotic for schizophrenia and bipolar disorder is in Phase III clinical trials. Solvay says it will offer efficacy equivalent to currently marketed therapies with a better safety profile.

22. Paliperidone Johnson & Johnson
FDA action is expected soon on this antipsychotic Risperdal follow-on.

23. Arformoterol Sepracor
Sepracor has high hopes for the nebulized long-acting bronchodilator, for which the company recently released encouraging efficacy data in Europe.

24. Tykerb GlaxoSmithKline
The small molecule dual kinase inhibitor for breast cancer is in late-stage development.

25. MK-0518 Merck
A leader in the investigational class of antiretrovirals called integrase inhibitors (for HIV), MK-0518 has demonstrated potential in Phase II clinical trials when matched against Sustiva.

26. Licarbazepine (AKA LIC477D) Novartis
The voltage-gated sodium channel inhibitor for psychosis and bipolar disorder is in Phase III clinical trials.

27. Saxagliptin Bristol-Myers Squibb
The DPP-IV drug is in Phase III clinical trials for the treatment of Type 2 diabetes.

28. Vatalanib (AKA PTK787/ZK 222584) Novartis/Berlex
The colorectal cancer drug, from the family of protein tyrosine kinase inhibitors and VEGF receptor kinase inhibitors, has been tested in mesotheliomas.

29. Zeven Pfizer
The antibiotic, which Pfizer acquired through Vicuron, has shown promise in treating drug-resistant strains of bacteria. Pfizer expects approval next year.

30. Rosiglitazone GlaxoSmithKline
The drug, linchpin of GSK’s Alzheimer’s hopes, is in Phase III clinical trials.

31. BAY 74-4113 Bayer/Pfizer
The compound for Type II diabetes and obesity,  in Phase I development, is the leader in an
innovative class of compounds that modify lipid metabolism.

32. Fesoterodine Pfizer/Schwarz Pharma
Pfizer has licensed the overactive bladder drug, which has been submitted to both FDA and the EU.

33. Redona GlaxoSmithKline
Glaxo’s DPP-IV inhibitor for the treatment of Type 2 diabetes is in Phase III clinical trials.
 
34. enzastaurin Eli Lilly & Co.
The cancer drug is in Phase III clinical trials for glioblastoma and non-Hodgkin’s lymphoma.

35. Arzoxifene Eli Lilly & Co.
The SERM is in clinical trials for use against breast cancer and osteoporosis, and could come to market by 2009.

36. BR3-Fc Genentech
This compound, which acts on the regulation of B-cells, is in early development for the possible treatment of rheumatoid arthritis and Sjögren’s Syndrome.

37. Mapatumumab GlaxoSmithKline/Takeda/Human Genome Sciences
The agnostic monoclonal antibody is considered a contender for the oncology field.

38. Aviptadil Biogen Idec
The drug, which Biogen Idec licensed from Swiss biotech mondoBIOTECH, is in early development for pulmonary arterial hypertension.

39. RSD-1235 Cardiome/Astellas
Astellas is resubmitting an NDA for the drug, for atrial fibrillation (antiarrhythmic).

40. Nebivolol Forest Labs
Forest has filed an NDA for the long-acting, cardioselective beta blocker for hypertension.

From the October 01, 2006 Issue of MM+M - Medical Marketing and Media