AstraZeneca plc (ADR) (NYSE:AZN) said that it is reviewing its options on the question of the compulsory license to produce diabetes drug in India. The company has been blamed for not selling its diabetes drug, Onglyza, at an affordable rate in India. As a result, Indian drug firm, Lee Pharma filed for a compulsory license to make a type of Onglyza since supplies are not adequate. However, the company maintained that it has been providing the drug at an affordable cost not only in India but everywhere.
Third Time
This is the third time that a drug maker from India is trying to win a compulsory license for not only making but also selling the generic type of a brand-name drug. AstraZeneca plc (ADR) (NYSE:AZN) and other global pharmaceutical companies are closely monitoring the developments in India. The reason was very simple. The sector is looking for a change of signs from the government on its approach in protecting the patent rights.
The company’s spokesperson has reportedly said that the drug maker has full faith in its intellectual property rights protecting its inventions. The British drug maker does not believe that there is any barrier including intellectual property to provide access to medicines in the developing nations.
Priority Watch List
AstraZeneca plc (ADR) (NYSE:AZN) alone was not facing the issue in India. There are other pharmaceutical firms that are not happy with the Indian court ruling that denied a patent for a cancer drug sold by Novartis AG (NYSE:NVS) two years back. As a result, the United State has put India on the priority watch list for nations, which failed to safeguard, as well as, enforce the patent rights.
The pharmaceutical firms are also facing push back since enforcing intellectual property rights will be at the cost of patients, who could not afford to spend for medicines. Compulsory license is cited as a classic example. AstraZeneca plc (ADR) (NYSE:AZN) is only hoping for a better fortune in India.
AstraZeneca PLC (AstraZeneca), incorporated on June 17, 1992, is a global biopharmaceutical company. The Company discovers, develops and commercializes prescription medicines for Cardiovascular and Metabolic diseases; Oncology; Respiratory, Inflammation and Autoimmunity, Infection, Neuroscience and Gastrointestinal. The Company’s medicines include Crestor for managing cholesterol levels; Seloken/Toprol-XL for hypertension, heart failure and angina; Onglyza for Type 2; Iressa for lung cancer; Faslodex for breast cancer; Zoladex for prostate and breast cancer; Pulmicort for asthma; Symbicort for asthma and COPD (chronic obstructive pulmonary); Nexium for acid-related diseases; Seroquel XR for schizophrenia, bipolar disorder and depressive disorder, and Synagis for RSV (respiratory syncytial virus), a respiratory infection in infants. The Company’s pipeline includes 133 projects, of which 118 are in the clinical phase of development. AstraZeneca operates in over 100 countries.
Cardiovascular and Metabolic diseases
The Company’s marketed products under cardiovascular area include Atacand is an angiotensin II antagonist used for the 1st line treatment of hypertension and symptomatic heart failure; Brilinta/Brilique (ticagrelor) is an oral antiplatelet for acute coronary syndromes (ACS); Crestor (rosuvastatin calcium) is a statin for dyslipidaemia and hypercholesterolemia; Plendil (felodipine) is a calcium antagonist for hypertension and angina; Seloken/Toprol-XL (metoprolol succinate) is a beta-blocker once daily tablet for 24-hour control of hypertension, and heart failure and angina; Tenormin (atenolol) is a cardio-selective beta-blocker for hypertension, angina pectoris and other CV disorders, and Zestril (lisinopril dihydrate) is an angiotensin-converting enzyme inhibitor for a range of CV diseases, including hypertension. The Company’s marketed products under metabolic area include Byetta (exenatide injection) is an injectable medicine indicated to improve blood sugar (glucose) control, along with diet and exercise in adults with Type 2 diabetes mellitus; Bydureon (exenatide extended-release for injectable suspension) is a once weekly injectable medicine indicated to improve blood sugar (glucose), along with diet and exercise in adults with Type 2 diabetes mellitus; Bydureon Pen (exenatide extended-release for injectable suspension) delivers exenatide through microsphere technology in a once weekly dose requiring no titration; Farxiga/Forxiga (dapagliflozin) is a selective inhibitor of human sodium-glucose co-transporter 2 (SGLT-2 inhibitor) to improve glycaemic control in adult patients with Type 2 diabetes mellitus; Kombiglyze XR (saxagliptin and metformin XR) combines saxagliptin (Onglyza) and metformin extended release metformin (metformin XR) in a once daily tablet for Type 2 diabetes mellitus; Komboglyze (saxagliptin and metformin HCl) combines saxagliptin (Onglyza) and metformin immediate release (metformin IR) in a twice daily tablet for Type 2 diabetes mellitus; Myalept5 (metreleptin for injection) is a recombinant analogue of human leptin indicated in the United States as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy; Onglyza (saxagliptin) is an oral dipeptidyl peptidase 4 (DPP-4) inhibitor for Type 2 diabetes mellitus; Symlin (pramlintide acetate) is an injected amylin analogue for Type 1 and Type 2 diabetes mellitus in patients with inadequate glycaemic control on meal time insulin; Xigduo (dapagliflozin and metformin hydrochloride) combines dapagliflozin (Farxiga/Forxiga), an SGLT-2 inhibitor, and metformin hydrochloride, in a twice daily tablet to improve glycaemic control in adult patients with Type 2 diabetes mellitus who are inadequately controlled by metformin alone, and Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) combines dapagliflozin (Farxiga/Forxiga), an SGLT-2 inhibitor, and metformin hydrochloride extended-release, in a once daily tablet to improve glycaemic control in adult patients with Type 2 diabetes mellitus who are inadequately controlled by metformin alone.
Oncology
The Company markets a range of oncology products. The Company’s products include Arimidex (anastrozole) is an aromatase inhibitor used to treat breast cancer; Caprelsa (vandetanib) is a kinase inhibitor indicated to treat aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease; Casodex (bicalutamide) is an anti-androgen therapy used to treat prostate cancer; Faslodex (fulvestrant) is an injectable estrogen receptor antagonist used to treat hormone receptor positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy; Iressa (gefitinib) is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that acts to block signals for cancer cell growth and survival in EGFR mutation-positive (EGFR M+) advanced non-small cell lung cancer (NSCLC); Nolvadex (tamoxifen citrate) is used breast cancer treatment outside the United States; Lynparza (olaparib) is an oral poly ADP-ribose polymerase (PARP) inhibitor approved in Europe for the treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, and Zoladex (goserelin acetate implant), in one and three month subcutaneous or intra-muscular injections, is a luteinising hormone-releasing hormone (LHRH) agonist used to treat prostate cancer, breast cancer and certain benign gynaecological disorders.
Respiratory, Inflammation and Autoimmunity
The Company markets a range of respiratory, inflammation and autoimmunity products. The Company’s products include Accolate (zafirlukast) is an oral leukotriene receptor antagonist used for the treatment of asthma; Bricanyl Turbuhaler (terbutaline in a dry powder inhaler) is a short-acting beta2-agonist used for the acute treatment of bronchial-obstructive symptoms in asthma and COPD; Duaklir Genuair (aclidinium/formoterol) is a dual bronchodilator (LAMA/LABA) intended for maintenance symptom control in COPD patients and is the only LAMA/LABA with evidence of effect on early morning, day and nighttime symptoms; Eklira Genuair/Tudorza/Bretaris (aclidinium, a LAMA) is a 1st line treatment for symptomatic mild to moderate COPD patients in need of maintenance therapy; Oxis Turbuhaler (formoterol in a dry powder inhaler) is an onset, long-acting beta2-agonist used for the treatment of bronchial-obstructive symptoms in asthma and COPD; Pulmicort Turbuhaler/Pulmicort Flexhaler (budesonide in a dry powder inhaler) is an inhaled corticosteroid used for maintenance treatment of asthma; Pulmicort Respules1 (budesonide inhalation suspension) is a corticosteroid administered via a nebulizer for the treatment of asthma in both children and adults; Rhinocort (budesonide) is a nasal steroid used as a treatment for allergic rhinitis (hay fever), perennial rhinitis and nasal polyps; Symbicort pMDI (budesonide/formoterol in a pressurised metered-dose inhaler) is a combination of an inhaled corticosteroid and a fast onset, long-acting beta2-agonist used for maintenance treatment of asthma and COPD, including chronic bronchitis and emphysema in the United States, Australia and some other markets, and Symbicort Turbuhaler (budesonide/formoterol in a dry powder inhaler) is a combination of an inhaled corticosteroid and a fast onset, long-acting beta2-agonist used for the maintenance treatment of asthma and COPD.
Infection, Neuroscience and Gastrointestinal
The Company markets a range of infection, neuroscience and gastrointestinal products. The Company’s products include Synagis (palivizumab) is a humanised MAb used to prevent serious lower respiratory tract disease caused by RSV in paediatric patients at high risk of acquiring RSV disease; Cubicin (daptomycin) is a cyclic lipopeptide anti-bacterial used to treat serious infections in hospitalised patients; Merrem/Meronem (meropenem) is a carbapenem anti-bacterial used to treat serious infections in hospitalised patients; Zinforo (ceftaroline fosamil) is an injectable cephalosporin used in community-acquired pneumonia and complicated skin and soft tissue infections; FluMist/Fluenz (influenza vaccine live, intra-nasal) is an intra-nasal, live, attenuated, trivalent influenza vaccine, and FluMist Quadrivalent/Fluenz Tetra (influenza vaccine live, intra-nasal) is an intra-nasal, live, attenuated, quadrivalent influenza vaccine.
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