Pharma Industry On Track for a Strong Year for New Molecular Entities
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As of mid-December 2014, the US Food and Drug Administration has approved 35 new molecular entities, putting 2014 on a pace for a strong year for new drug innovation.

The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is an important barometer for the pharmaceutical industry of R&D productivity and potential growth for new products. As of mid-December, the FDA’s CDER has approved 35 NMEs, surpassing last year’s total of 27 NME approvals and nearing a recent high of NME approvals of 39 in 2012. But the number of NME approvals alone does not tell the whole story. What is the market potential of the new drugs, which companies have fared the best, and what is the mix between small molecules and biologics? DCAT Value Chain Insights (VCI) examines NME approvals thus far in 2014.

NME Approvals in 2014
As of December 15, 2014, the FDA’s Center for Drug Evaluation and Research (CDER) has approved 35 NMEs, 24 new drug applications (i.e., small molecules) and 10 biologics license applications (BLAs) (see Table I at the end of the article). In comparison, FDA’s CDER approved 27 NMEs in 2013 and 39 NMEs in 2012, a recent high. From 2004 to 2012, CDER averaged 26 NME approvals per year, which was bolstered by approval levels in 2012 and 2013. The period of 2005 to 2010 was a slower period for NME approvals. In 2005, 20 NMEs were approved, 22 in 2006, 18 in 2007, 24 in 2008, and 26 in 2009.

Reflecting in some cases, the more niche and targeted focus on drug development, of the 35 NMEs approved thus far in 2014, 15 NME approvals were for rare diseases; the previous high was 13 drugs in 2012. Reflecting greater levels of innovation, 15 of the NME approvals thus far in 2014 have been for first-in-their class drugs, another indicator of their potentially strong clinical impact.

Also, seven of the NMEs approved thus far in 2014 were granted breakthrough therapy designation by the FDA. A breakthrough therapy is a drug intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. If a drug is designated as a breakthrough therapy, the FDA will expedite the development and review of such a drug. Thus far in 2014, seven NMEs with breakthrough therapy status have been approved by the FDA: Novartis’ Zykadia (certinib), a drug to treat a certain type of metastatic non-small cell lung cancer; Gilead Sciences’ Zydelig (idelalisib), a drug to three types of blood cancer; Merck & Co,’s Keytruda (pembrolizumab) for treating metastatic melanoma; Boehringer Ingelheim’s Ofev (nintedanib) and Roche’s Esbriet (pirfenidone), both for treating idiopathic pulmonary fibrosis; Gilead Sciencs’ combination therapy, Harvoni (ledipasvir and sofosbuvir), for treating chronic hepatitis C virus (HCV) genotype 1 infection; and Amgen’s Blincyto (blinatumomab) for treating patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.

With regard to the mix between small molecules and biologics, the level of bilogics approvals increased in 2014. The 10 BLAs NMEs approved thus far in 2014 represents a high for NME approvals for biologics. In 2013, only two BLAs were approved and six NME BLAs were approved in each of the following years: 2009, 2010, 2011, and 2012. The 10 NME BLA approvals in 2014 thus far are: Amgen’s Blincyto (blinatumonmab) for treating a rare form of leukemia; AstraZeneca’s Myalept (metreleptin) for treating a rare form of high cholesterol; Biogen Idec’s Plegridy (peginterferon beta-1a) for treating relapsing forms of multiple sclerosis; BioMarin Pharmaceutical’s Vimizim (elosulfase) for treating the rare disease, Mucopolysaccharidosis Type IVA; two biologics by Eli Lilly, Trulicity (dulaglutide), a drug to treat Type II diabetes, and Cyramza (ramucirumab), a drug to treat a rare form of stomach cancer; GlaxoSmithKline’s (GSK) Tanzeum (albiglutide), a drug to treat Type II diabetes; Janssen Biotech’s Sylvant (siltuximab), a drug to treat multicentric Castleman’s disease, a rare disorder similar to lymphoma; Merck & Co’s Keytruda; and Takeda’s Entyvio (vedolizumab), a drug to treat moderate-to-severe ulcerative colitis and severe Crohn’s disease in adults.  

Pharma company activity
Among the pharma companies, which companies have led with NMEs approvals thus far in 2014? AstraZeneca, Boehringer Ingelheim, and Merck & Co. lead the pack, each with three NME approvals. AstraZeneca received FDA approval for Farxiga (dapaglifozin) for treating Type II diabetes, the orphan drug Myalept (metreleptin), and Movantik (naloxegel), a drug to treat opiod-induced constipation in adults with chronic non-cancer pain. Farxiga was approved by the FDA in January 2014. It was approved in Europe, where it is marketed as Forxiga, in November 2012 and in Japan in March 2014. Farxiga was the second drug approved by FDA in a new class of drugs to treat diabetes, sodium glucose cotransporter 2 (SGLT2) inhibitors. The first was Janssen Pharmaceuticals’ Invokana (canagliflozin), which was approved in 2013. As a SGLT2 inhibitor, Farxiga blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. It is indicated as an adjunct to diet and exercise as a once-daily oral medication to improve glycemic control in adult patients with Type 2 diabetes mellitus as an add-on combination therapy or as monotherapy in metformin-intolerant patients. Myalept is a recombinant analog (laboratory-created form) of human leptin as a replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. AstraZeneca gained full rights to Farxiga as well as to Myalept as part of its $2.7-billion acquisition of its diabetes alliance with Bristol-Myers Squibb, a deal which was completed in February 2014. The acquisition gave AstraZeneca ownership of the intellectual property and global rights for the development, manufacture, and commercialization of the diabetes business, which included Farxiga/Forxiga, Xigduo (dapaglifozin and metformin HCl extended release), Onglyza (saxagliptin), Komboglyze (saxagliptin and metformin HCl), Kombiglyze XR (saxagliptin), Byetta (exenatide), Bydureon (exenatide extended-release for injectable suspension), metreleptin, and Symlin (pramlintide acetate). In addition to the $2.7-billion, AstraZeneca also agreed to pay up to $1.4 billion in regulatory, launch, and sales payments, and various sales-related royalty payments up until 2025, $600 million of which relates to the approval of Farxiga in the US. In addition, AstraZeneca may make payments of up to $225 million when certain assets are subsequently transferred.

In 2014, Boehringer Ingelheim received FDA approval for Ofev (nintedanib) for treating idiopathic pulmonary fibrosis, Jardiance (empagliflozin) for treating Type II diabetes and part of the diabetes alliance that the company has with Eli Lilly, and Striverdi Respimat (olodaterol), a respiratory drug. Ofev is a small-molecule tyrosine kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Nintedanib targets growth factor receptors involved in the mechanisms by which pulmonary fibrosis occurs. Most importantly, nintedanib, inhibits the platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and the vascular endothelial growth factor receptor (VEGFR). The FDA granted Ofev fast track, priority review, orphan product, and breakthrough therapy designations. Boehringer Ingelheim received FDA approval for Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Boehringer Ingelheim is also studying olodaterol as a possible future combination partner with Spiriva (tiotropium bromide inhalation powder), the company’s long-acting muscarinic antagonist for treating COPD.

Merck received FDA approval for Keytruda, Belsomra (suvorexant) for treating insomnia, and Zontivity (vorapaxar), an antiplatelet. Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.

Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling action of orexin in the brain. The FDA recommended that Belsomra be classified by the US Drug Enforcement Administration (DEA) as a scheduled product.  Zontivity is the first in a new class of drugs called protease-activated receptor-1 (PAR-1) antagonists. It is designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke. It was approved by the FDA to reduce the risk of heart attack, stroke, cardiovascular death, and the need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs

Eli Lilly and Gilead Science each had two NME approvals thus far in 2014. Eli Lilly received approval for Trulicity and Cyramza. Gilead Sciences received approval of its combination therapy, Harvoni (ledipasvirand sofosbuvir), for treating chronic hepatitis C virus (HCV) genotype 1 infection, and for Zydelig for treating three types of blood cancer. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It was also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir. Harvoni was the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013. Sofosbuvir is Gilead’s top-selling drug. It had sales of $8.550 billion for the first nine months of 2014. It was approved by the FDA in December 2013 as the first all-oral interferon-free regimen for treating CHC. It was approved as a component of a combination antiviral treatment regimen.

Gilead Sciences also received approval for Zydelig (idelalisib), which is indicated to treat three types of blood cancer. Zydelig was approved to treat patients whose chronic lymphocytic leukemia has returned (relapsed) as well to two treat two other indications: relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma, another type of non-Hodgkin lymphoma.

Amgen, Biogen Idec, Eisai (with Helsinn), GSK, Novartis, Sanofi, and Takeda each gained one NME approval thus far in 2014. Amgen received FDA approval for Blincyto, the first approved drug that engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. The FDA granted Blincyto breakthrough therapy designation, priority review, and orphan product designation. Helsinn’s Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy. Akynzeo is distributed and marketed by Eisai under license from Helsinn Healthcare S.A.

Biogen Idec received FDA approval for Plegridy (peginterferon beta-1a) as a treatment for adults with relapsing forms of multiple sclerosis. Plegridy is dosed once every two weeks and is administered subcutaneously with the Plegridy Pen, a new ready-to-use autoinjector, or a prefilled syringe. Plegridy is interferon beta-1a that has been pegylated to extend its half-life to permit a less frequent dosing schedule.

GSK received approval for its biologic, Tanzeum for treating Type I diabetes.  Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist is a biological product for treating Type 2 diabetes and administered once-weekly using an injector pen. It is a recombinant fusion protein comprised of two tandem copies of modified human GLP-1 genetically fused in tandem to human albumin. Glucagon-like peptide-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with Type 2 diabetes, its production is often reduced or absent, according to a GSK press release. In gaining approval for Tanzeum, GSK will be competing against other GLP-1 agonists: AstraZeneca’s Byetta (exenatide injection) and Bydureon (exenatide extended-release injectable suspension) and Novo Nordisk’s Victoza (liraglutide), and Sanofi’s Lyxumia (lixisenatide) Lyxumia was in-licensed from Zealand Pharma A/S and is approved in Europe for the treatment of adults with Type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lyxumia is also approved in Mexico, Australia, Japan, and Brazil for the treatment of adults with Type 2 diabetes. Sanofi plans to resubmit the new drug application for lixisenatide in the United States in 2015 after completion of a cardiovascular outcomes study.

Novartis received approval for its drug, Zykadia (ceritinib), for treating a certain type of metastatic non-small cell lung cancer. Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive non-small cell lung cancer who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor.

Roche, through its acquisition of InterMune earlier in 2014, gained FDA approval for Esbriet (pirfenidone) for treating idiopathic pulmonary fibrosis. Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue. it is believed to interfere with the production of transforming growth factor (TGF)-beta, a small protein in the body involved in how cells grow and tumor necrosis factor (TNF)-alpha, a small protein that is involved in inflammation. The FDA granted Esbriet fast track, priority review, orphan product, and breakthrough designations.

Sanofi, through its Genyzme subsidiary, gained approval for Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type I form of Gaucher disease, a rare genetic disorder. The drug also received orphan drug status from the FDA. The new oral drug was developed by Sanofi’s Genzyme subsidiary, which also developed Cerezyme (imiglucerase for injection), which is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease. Cerezyme posted 2013 sales of EUR 688 million ($913 million) and is one of several enzyme-replacement therapies by Sanofi to treat rare diseases. Others are: Myozyme/Lumizyme (alglucosidase alfa) to treat Pompe disease,Fabrazyme (agalsidase beta) to treat Fabry disease, and Aldurazyme (laronidase) to treat mucopolysaccharidosis Type I.

Takeda Pharmaceutical received approval for its NME, Entyvio (vedolizumab) injection, for treating adult patients with moderate-to- severe ulcerative colitis and adult patients with moderate-to-severe Crohn‘s disease. Entyvio is an integrin receptor antagonist. Integrin receptors are proteins expressed on the surface of certain cells. Integrin receptors function as bridges for cell-cell interactions. Entyvio blocks the interaction of a specific integrin receptor (expressed on circulating inflammatory cells) with a specific protein (expressed on cells in the interior wall of blood vessels), and thereby blocks the migration of those circulating inflammatory cells across those blood vessels and into areas of inflammation in the gastrointestinal tract.

Examining other approvals
Other companies received approvals of orphan drugs. Janssen Biotech received FDA approval for an orphan drug, Sylvant (siltuximab), to treat patients with multicentric Castleman’s disease. Chelsea Therapeutics, which was acquired by H. Lundbeck A/S (Lundbeck) for $658 million in June 2014, received approval for its orphan drug, Northera (droxidopa), for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic drop in blood pressure upon standing that is associated with Parkinson’s disease, multiple-system atrophy, and pure autonomic failure, dopamine beta hydroxylase deficiency, and non-diabetic autonomic neuropathy.

Also, in 2014, the FDA approved three QIDP-designated antibacterial drugs, a designation by the FDA for Qualified Infectious Disease Products (QIDPs), which provides an incentive for developing multidrug-resistant antibiotics. Under the QIDP designation, FDA provides priority review, and the drug also receives fast-track designation at the sponsor’s request. At the time of approval, a product with QIDP designation may be eligible for an additional five years of marketing exclusivity by having exclusive marketing rights without competing with a generic drug product. The first three QIDP-designated antibacterial drugs were approved by the FDA in 2014: Durata Therapeutics’ Dalvance (dalbavancin) in May 2014; Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate) in June 2014; and The Medicines Company’s Orbactiv (oritavancin) in August 2014. Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria such as Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. Actavis recently acquired Durata Therapeutics, and earlier this month Merck & Co. agreed to acquire Cubist for $9.5 billion. Sivextro and Orbactiv are also approved to treat patients with ABSSSI caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis.

Table I: 2014 New Molecular Entities (New Drug Applications (NDA) and Original Biologics License Applications (BLAs) Approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research (as of December 15, 2014).
Company Property name (active ingredient); application type Indication
Actavis/Durata Therapeutics Dalvance (dalbavancin); NDA Acute bacterial skin and skin structure infections
Amgen Blincyto (blinatumomab); BLA Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia
Anacor Pharmaceuticals Kerydin (tavaborole); NDA Onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes
AstraZeneca Farxiga (dapaglifozin); NDA To improve glycemic control, along with diet and exercise, in adults with Type 2 diabetes
AstraZeneca Myalept (metreleptin); BLA To treat metabolic disorders secondary to lipodystrophy
AstraZeneca Movantik (naloxegol); NDA Opioid-induced constipation in adults with chronic non-cancer pain
Biogen Idec Plegridy (peginterferon beta-1a); BLA Relapsing forms of multiple sclerosis
BioMarin Pharmaceutical Vimizim (elosulfase alfa); BLA To treat Mucopolysaccharidosis Type IVA (Morquio A syndrome)
Boehringer Ingelheim Ofev (nintedanib); NDA Idiopathic pulmonary fibrosis
Boehringer Ingelheim Jardiance (empagliflozin); NDA To improve gylcemic control in adults with Type 2 diabetes
Boehringer Ingelheim Striverdi Respimat (olodaterol); NDA Long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema
Bracco Diagnostics Lumason (sulfur hexafluoride lipid microsphere); NDA    Imaging agent for ultrasound image of the heart (echocardiograms) that are hard to see with ultrasound waves
Celgene Otezla (apremilast); NDA To treat adults with active psoriatic arthritis
Cubist Pharmaceuticals Sivextro (tedizolid phosphate); NDA Acute bacterial skin and skin structure infections
Eli Lilly and Company Trulicity (dulaglutide); BLA Type II diabetes
Eli Lilly and Company Cyramza (ramucirumab); BLA Advanced stomach cancer or gastroesophageal junction adenocarcinoma
Gilead Sciences Harvoni (ledipasvir and sofosbuvir); NDA Chronic hepatitis C virus (HCV) genotype 1 infection
Gilead Sciences Zydelig (idelalisib); NDA To treat three types of blood cancer
GlaxoSmithKline Tanzeum (albiglutide); BLA To improve glycemic control, along with diet and exercise, in adults with Type 2 diabetes.
Helsinn Healthcare Akynzeo (netupitant and palonosetron); NDA To treat nausea and vomiting in patients undergoing cancer chemotherapy
Janssen Biotech Sylvant (siltuximab); BLA Multicentric Castleman’s disease
Lunbeck/Chelsea Therapeutics Northera (droxidupa); NDA Neurogenic orthostatic hypotension
Knight Therapeutics Impavido (miltefosine); NDA Leishmaniasis
Merck & Co. Inc. Keytruda (pembrolizumab); BLA Advanced or unresectable melanoma
Merck & Co. Inc. Belsomra (suvorexant); NDA To treat difficulty in falling and staying asleep (insomnia)
Merck & Co. Inc. Zontivity (vorapaxar); NDA To reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs
Novartis Zykadia (ceritinib); NDA A certain type of metastatic non-small cell lung cancer
Piramal Imaging Neuraceq (florbetaben F 18 injection); NDA Imaging agent for positron emission tomography imaging of the brain
Roche/InterMune Esbriet (pirfenidone); NDA Idiopathic pulmonary fibrosis
Sanofi/Genzyme Cerdelga (eliglustat); NDA Long-term treatment of adult patients with the Type 1 form of Gaucher disease
Spectrum Pharmaceutical Beleodaq (belinostat); NDA Peripheral T-cell lymphoma
Takeda Pharmaceutical Entyvio (vedolizumab); BLA Moderate-to-severe ulcerative colitis and severe Crohn‘s disease in adults
The Medicines Company Orbactiv (oritavancin); NDA Acute bacterial skin and skin structure infections caused by certain susceptible bacteria
Valeant Pharmaceuticals Jublia (efinaconazole); NDA Onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes
Vanda Pharmaceuticals Hetlioz (tasimelteon); NDA o treat non-24-hour sleepwake disorder in blind individuals without light perception
Actavis acquired Durata Therapeutics in 2014.

AstraZeneca completed the acquisition of its diabetes alliance from Bristol-Myers, which include Myalept, in February 2014. As part of the sale of its diabetes alliance (excluding China) to AstraZeneca, Bristol-Myers Squibb received from AstraZeneca a payment of approximately $2.7 billion at closing and a subsequent milestone payment of $600 million for the US approval of Farxiga (dapagliflozin). The company also received $100 million for the approval of dapagliflozin in Japan. Bristol-Myers Squibb will potentially receive additional regulatory- and sales-based milestone payments from AstraZeneca of up to $700 million, royalty payments based on net sales through 2025, and additional payments if and when certain assets are subsequently transferred.

Akynzeo is distributed and marketed by Eisai Inc. of Woodcliff Lake, New Jersey, under license from Lugano, Switzerland-based Helsinn Healthcare S.A.

Boehringer Ingelheim and Eli Lilly partnered for Jardiance as part of the companies’ diabetes alliance.

Lundbeck acquired Chelsea Therapeutics in June 2014.

Knight Therapeutics Inc. was formed from the former shareholders of Paladin Labs Inc pursuant to a spin-off transaction made in February 2014; Paladin was acquired by Endo Health Solutions Inc., a specialty pharmaceutical company.

Merck & Co. agreed to acquire Cubist Pharmaceuticals in December 2014.

Roche acquired InterMune in 2014.

Valeant Pharmaceuticals acquired Jublia (efinaconazole) from its 2008 acquisition of Dow Pharmaceutical Science.

Source: US Food and Drug Administration.

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