Polypeptide drugs rush to “blockbuster” upstart
In the field of recombinant drugs, peptide drugs have become the best choice for patients because of their unique advantages such as low toxicity, high specificity and small molecular weight. In addition, with the improvement of manufacturing technology and drug delivery system, peptide drugs have made rapid development since the launch of lypressin (lysine vasopressin) of Novartis in the 1970s.
According to the report of the global peptide therapy foundation, in the past few decades, the number of peptide drugs entering clinical development has been increasing, with an average of 9.7 in the 1990s, and increased to 16.8 from 2000 to 2008.
From 2000 to 2008, cancer and metabolic diseases (including diabetes and obesity) were the most common indications of peptides entering clinical research, accounting for 18% and 17% respectively. However, the research of polypeptide drugs for the treatment of allergy, immune dysfunction and cardiovascular disease has declined.
According to bionest partners, the leading strategy and management consulting firm of the life science industry, the global peptide drug market will grow from $5.3 billion in 2003 to $11.5 billion in 2013, with a CAGR of 8.1%. In the global pharmaceutical market, several polypeptide drugs have achieved commercial success, and their sales have reached or approached the sales level of “blockbuster” drugs.
Xingui 1: grantirel acetate
Copaxone, a key product of TIVA pharmaceutical company in Israel, is a synthetic peptide preparation, which is composed of four amino acids: glutamic acid, alanine, tyrosine and lysine. Copaxone was approved by FDA in 1996 to treat multiple sclerosis. In western countries with more patients with multiple sclerosis, the efficacy and tolerability of Copaxone have been fully affirmed.
At present, there is no domestic enterprise to declare gratirel or import. In 2011, the global sales of Copaxone reached 3.6 billion US dollars. It is reported that in the first quarter of this year, sales of the drug reached $909 million. In June, Teva said in its annual economic forecast that the drug could generate up to $3.8 billion in revenue this year. But Copaxone’s sizable earnings also pose challenges for generic companies.
Recently, TIVA pharmaceutical company announced that it had launched a lawsuit against several pharmaceutical companies including momenta biopharmaceutical company, Sandoz branch of Novartis pharmaceutical company, mylan pharmaceutical company and NATCO biopharmaceutical company for the patent right of Copaxone. A few days ago, the New York state court said that TIVA pharmaceutical company won the lawsuit. TIVA’s exclusive marketing rights for the drug will be extended to 2014.
Xingui 2: leuprorelin acetate
Abbott’s Lupron (leuprorelin acetate) is a synthetic nine peptide analogue of GnRH or LH-RH. Lupron has a wide range of indications, including endometriosis; hysteromyoma with menorrhagia, abdominal pain, low back pain and anemia; premenopausal breast cancer and estrogen receptor positive patients; prostate cancer; central precocious puberty.
In 2011, Abbott’s Lupron had global sales of $810 million. In the Chinese market, Takeda Pharmaceutical Industry Co., Ltd. has been importing and selling since 2000. In 2009, Beijing Bonte Pharmaceutical Co., Ltd. and Shanghai Lizhu Pharmaceutical Co., Ltd.
listed domestic leuprorelin acetate. In recent two years, the use of leuprorelin acetate in sample hospitals of 16 key cities in China has increased rapidly, with the growth rate maintained at about 50%, reaching 57.3 million yuan in 2011. Among the domestic leuprorelin acetate market share, Takeda Pharmaceutical Industry Co., Ltd. occupies 86.73 market share.
Xingui 3: goserelin acetate
Noread (goserelin acetate) of AstraZeneca is a luteinizing hormone releasing hormone analogue for injection. It is used for palliative treatment of advanced prostate cancer, premenopausal and perimenopausal advanced breast cancer, endometriosis and uterine fibroma.
In 2011, the global sales of AstraZeneca norade reached 1.1 billion US dollars. In the Chinese market, the former British jerichon company has been importing and selling since 1999. After Astra and jerichon merged into AstraZeneca, Astra will continue to import and sell by AstraZeneca. From 2007 to 2011, the drug use of goserelin acetate in sample hospitals of 16 key cities in China maintained a rapid growth. Although it slowed down slightly in 2010, the growth rate was still above 30%. In 2011, the drug use of goserelin acetate in sample hospitals of 16 key cities in China reached 190 million yuan.
Xingui 4: octreotide acetate
Novartis Sandostatin (octreotide acetate) is a synthetic octreotide derivative of natural somatostatin. It retains similar pharmacological effects as somatostatin and has long-lasting effects. The indications of octreotide acetate include acromegaly, relieving symptoms and signs related to functional gastrointestinal and pancreatic endocrine tumor, and effective for carcinoid tumor, VIP tumor and glucagon tumor with carcinoid syndrome.
In addition, the effective rate of octreotide acetate on gastrinoma / Zollinger Ellison syndrome (usually combined with proton pump inhibitors or H2 receptor blockers), insulinoma (preoperative prevention of hypoglycemia and maintenance of normal blood glucose), and growth hormone releasing factor tumor was about 50%.
In 2011, Novartis sunning’s global sales were $1.4 billion. In the Chinese market, Novartis began to import and sell in 1999. In addition, India sun Pharmaceutical Co., Ltd. also began to import and sell in 2009. There are more than 20 domestic products on the market. In 2011, the amount of octreotide acetate used in hospitals in 16 key cities in China reached 183 million yuan, of which Novartis accounted for half of the total, accounting for 52.77%.
Xingui 5: exenatide
Exenatide from Lilly / amylin pharmaceutical company is the first incretin mimics. It is a synthetic peptide amide composed of 39 amino acids, which is a subcutaneous injection. Adjuvant therapy for improving blood glucose control is used in patients with type 2 diabetes who are taking the sulfonylurea drug metformin or sulfonylurea compound but cannot effectively control blood glucose.
However, since the drug may cause acute pancreatitis and renal function changes, FDA has repeatedly warned the drug and asked to revise the instructions.
In 2011, the global sales of barida were $423 million for Lilly and $518 million for amylin. In the Chinese market, Patel began to import and sell in 2009. In 2011, exenatide in 16 key cities in China reached 6.86 million yuan.
Xingui 6: tripatide
Lilly’s parathyroid hormone tetrapeptide was first approved for use in postmenopausal women with osteoporosis, early-stage or hypogonadism in male patients with osteoporosis, and then added new indications for the treatment of osteoporosis associated with persistent, whole body glucocorticoid treatment in high-risk fracture treatment.
In 2011, the global sales of tetrapeptide reached US $951 million. In the Chinese market, Lilly (France) began to import in 2011.
Dr. Steven Chu, a famous American scientist and Nobel laureate, said: “the bioengineering in the 21st century is to study genetic engineering and protein engineering, and the 21st century is the century of polypeptide.
”From the domestic situation, since 2011, peptide drugs have been favored by more capital. In June and July last year, two Chinese pharmaceutical listed companies, hipray and Haiwang biology, both said they would enter the polypeptide industry. According to the relevant securities media survey, since the second quarter of last year, public funds and private institutions have quietly added positions in peptide listed pharmaceutical companies.
With the reduction of raw material cost, scale efficiency and progress of separation technology, the cost of chemical peptide synthesis, especially solid-phase peptide synthesis, has decreased significantly. The market of chemical synthetic peptide drugs in China will usher in a new round of expansion.
Source: medical economic news
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