Spectrum (formerly Nativa)

Nativa is a strategic partner of the Ministry of Industry and Trade of Russia within the framework of the federal target program Pharma 2020. The Company is the executor of state contracts in the field of technology development and organization of production of vital and essential medicines not previously produced by domestic manufacturers in the Russian Federation.

Areas of activity

The main activity is the development and production of generic medicines, including those focused on the priorities of the state policy in the field of import substitution for use in the following areas:

• Pulmonology
• Endocrinology
• Oncology
• Gynecology
• Neurology.

Aktivs

The company offers a wide range of modern medicines. At the end of 2017, more than 40 types of drugs were produced under the Nativa brand, most of which are included in the list of vital drugs. The company's production facilities are located in the Krasnogorsk district of the Moscow region. Contract production was launched in Ufa and Kursk as part of an alliance with Pharmstandard JSC.

History

2023: Bankruptcy begins

On March 13, 2023, the Arbitration Court of the Moscow Region recognized the claims of the New Paradigm company to declare the Spektr company bankrupt (previously called Nativa) and introduced a monitoring procedure against it.

As Vedomosti writes with reference to the case file, the total debt of the pharmaceutical company to the New Paradigm is 141.7 million rubles. In early July 2021, the New Paradigm debt itself was bought out under a cession agreement from Mammoth Farm LLC.

The total debt of the company is 141.7 million rubles

The reason for the trial was Nativa's failure to comply with the terms of the transaction during 2019-2021. So, in 2016, an agreement on the production and distribution of drugs was concluded between ARS LLC (copyright holder), Nativa LLC (manufacturer) and Mammoth Farm LLC (supplier of the substance). In June 2021, Mammoth Farm LLC transferred to New Paradigm LLC the right to claim Nativa LLC under this agreement. The New Paradigm company fulfilled its obligations and delivered pharmaceutical materials to Nativa for 141.7 million rubles, but the recipient did not pay the order.

In November 2021, the New Paradigm appealed to the Arbitration Court with a claim to recover the debt - it was satisfied in full, but the funds were never paid. In August 2022, the plaintiff announced his intention to apply to the court with an application for bankruptcy of Nativa, and in January 2023 the application was sent to the Arbitration Court.

The "new paradigm" belongs to Kirill Boyko (by March 2023). He heads Farmmental Group, which transferred the rights to a significant part of the drugs of the former Nativa, including anti-tumor sunitinib, erlotinib, dasatinib, gefitinib and others. On "Nativa" there is a regu-confidence in the only drug - anti-epileptic etosuximide. Nativa became known for bringing popular cancer drugs to the biosimilars market even before the expiration of the originators' patent.^[1]

2019

Confirmation in court of the right to use Sunitinib-nativ

On October 24, 2019, in the Intellectual Rights Court, a cassation appeal was heard on the claim of Pharmasia and Upjohn Campani LLC and Susan Ink LLC, which are members of the Pfizer group, to Nativa LLC and the Ministry of Health of the Russian Federation. This became known on October 28, 2019. The court refused to satisfy the claim in the case of A40-166505/17 in favor of Nativa. The demand of foreign companies to ban the use, manufacture and sale of an antitumor Russian drug with the trade name Sunitinib-nativ was rejected. And the counter-demand of Nativa to issue a license for the use of the invention, protected by Eurasian patent No. 005996 for the production of its own drugs of Nativa, is satisfied.

The decision of the court of first instance obliged the plaintiffs to provide a simple non-exclusive license for the invention of Nativa LLC for the production of medicines with INN Sunitinib. The appeal and cassation instances confirmed the legality and validity of the decision of the court of first instance. Thus, in judicial practice, the first full-fledged precedent appeared on the issuance of a simple non-exclusive license for a dependent invention.

The court decision provides for license payments from Nativa in the amount of 10% of the revenue side of the price of Sunitinib, which are calculated based on the registered maximum selling price for vital drugs with INN Sunitinib.

The right of Nativa to use the invention of a foreign corporation under patent protection for more than 20 years has been legally confirmed. In this situation, the consistency of court decisions is also very important, commented on the court decision Alexander Malin, General Director of Nativa LLC

This is the second decision to issue a license for a dependent invention on the account of a Russian company. Earlier, Nativa received a similar license for the production of a drug with INN Lenalidomide, the dispute over which ended with the signing of an amicable agreement with a foreign company Selgen International Holdings.

The antitumor active substance Sunitinib is an inhibitor of about 80 enzymes involved in the growth of a malignant tumor, in the formation of metastases and pathological angiogenesis, used for the treatment of renal cell carcinoma (RCC) and pancreatic cancer. About 24 thousand cases of the disease are registered annually, the growth rate exceeds 25%. The average mortality rate of Russian patients from malignant kidney tumors is 3.34 per 100 thousand population. The cost of the reproduced drug is 26% lower than the original. The drug is included in the list of the federal VED program.

Nativa confirms its right to produce domestic sunitinib

On April 22, 2019, Nativa announced that the Ninth Arbitration Court of Appeal confirmed the decision of the Moscow Arbitration Court of February 8, 2019 to grant the Russian company a license to use the patent to Farmasia and Upjohn Campeni, which, according to its representatives, is part of the Pfizer group of companies. Read more here.

The court rejected the appeal of Orion Corporation to Nativa

On March 5, 2019, Nativa reported that the Tenth Arbitration Court of Appeal confirmed the decision of the previous court - the Arbitration Court of the Moscow Region - that the Russian manufacturer did not violate the exclusive rights of Orion Corporation for a drug with INN Levosimendan. The drug product "Levosimendan-nativ" contains the active substance Levosimendan, protected by the patent of the Russian Federation No. 2118317, which has already expired. Orion Corporation lawyers failed to prove that the plaintiff's rights to the invention of "pharmaceutical solutions of Levosimendan" under Eurasian patent No. 005067, which is valid until 08.09.2020, are violated.

The patent the Finnish of the pharmaceutical company Orion Corporation protects the invention called "pharmaceutical solutions of Levosimendan," while the drug "Levosimendan-nativ," in question, has the form of a concentrate for preparing a solution for infusion. The concentrate and the solution are different dosage forms in accordance with the List of Names of Dosage Forms of Medicinal Products for Human Use approved by Order Ministry of Health Russia No. 538n of 27.07.2016.

author '= Alexander Malin, General Director of Nativa LLC ' The decision of the court is legal and justified. The claims of a foreign manufacturer do not have a logical basis, since the dosage form of a Russian-made drug differs from the one protected by a patent of a foreign company.

2018

The cassation court sided with Nativa in a dispute with AstraZeneca

On November 7, 2018, the Moscow Arbitration Court refused Astrazeneka Pharmaceuticals LLC to satisfy the cassation appeal in the A41-90766/2017 case. The operative part of the ruling was published on the court's website on November 12, 2018.

Astrazeneka Pharmaceuticals appealed to the Court of Cassation after refusing to satisfy its claims by the first two courts. For the first time, the complaint was filed by the plaintiff a year ago, the company demanded that the actions of Nativa LLC be recognized as unfair competition. According to the plaintiff, the defendant could mislead a wide range of persons regarding the consumer properties and quality of the domestic drug intended for the basic therapy of bronchial asthma.

In March, the Court of Appeal confirmed the decision of the court of first instance, and also decided to refuse to fulfill the requirements for changing the registration documents to Formisonides-nativ. As a result, the Arbitration Court of the Moscow District decided to leave the decision of the Arbitration Court of the Moscow Region on 19.03.2018 and the decision of the Tenth Arbitration Court of Appeal on 13.06.2018 in case No. A41-90766/2017 unchanged, and dismissed the cassation appeal.

The court once again confirmed the correctness of Nativa LLC, not finding signs of unfair competition in the company's actions. We consider the court's decision to be fair and legal, and its position to be consistent, "commented Yulia Gerasimova, Deputy General Director of Nativa LLC.

"Formisonide-nativ" is included by the Ministry of Health of the Russian Federation in the list of vital and essential drugs. The combined preparation contains formoterol and budesonide having different mechanisms of action. These active substances exhibit an additive effect with respect to the severity of the symptoms of bronchial asthma, the improvement of lung function and the reduction in the frequency of exacerbations of bronchial asthma and chronic obstructive pulmonary disease. The cost of the drug "Symbicort Turbuhaler" manufactured by AstraZenek costs from 770.1 to 2198.4 rubles per packaging. The price of the drug "Formisonide-nativ" is in the range of 330.6 - 3316.8 rubles, depending on the dosage and number of tablets. The foreign drug is also included in the VED list.

Victory in court over the Finnish Orion Corporation

On September 19, 2018, the Arbitration Court of the Moscow Region refused the Finnish company Orion Corporation to satisfy the requirements for Nativa LLC to terminate the violation of exclusive rights to the drug with INN Levosimendan. The resolution should be published in the public domain in the near future. The Ministry of Health of the Russian Federation is involved in the proceedings as a third party.

We are talking about a drug from the list of VEDs used for the treatment of heart failure. The Russian generic drug was registered with the State Register of Medicines in June 2017.

On February 22, 2018, the lawsuit was accepted by the court for production, on September 19, a decision was received to dismiss the claims of a foreign corporation against the Russian manufacturer. This decision is far from the first in the portfolio of successful litigation in favor of the Russian manufacturer. Earlier, the court recognized the correctness of the domestic pharmaceutical company in a dispute with foreign corporations Selgin Corporation, Bayer, Bristol-Myers Squibb, AstraZenek.

"We regard our successes in court as a change of attitude towards the domestic manufacturer by the state," commented Alexander Malin, General Director of the Nativa pharmaceutical company, on the company's victory. - INN levosimendan is an active substance of a new generation drug effective in the treatment of heart failure, which not only protects against myocardium, but also contributes to the rapid recovery of cardiac surgical patients after resuscitation. Cardiovascular disease continues to be one of the most common diseases among our citizens, despite significant national health gains in reducing the number of deaths. "

Registration of Goserelin as a subcutaneous implant

On September 25, 2018, the pharmaceutical company Nativa announced that it had registered a domestic drug with the international non-proprietary name Goserelin in the form of a subcutaneous implant. The drug with the trade name "Goserelin-long" is intended for the therapy of a number of oncological diseases. Until recently, the only manufacturer of the drug with this INN in Russia. Read more here

"Nativa" won in patent dispute with "Bristol-Myers Squibb"

The Arbitration Court of the Moscow Region decided to completely refuse Bristol-Myers Squibb Holdings Ireland to satisfy the claims against Nativa LLC in the A41-87845/2017 case. This was reported on June 25, 2018 by Nativa.

In October 2017, Bristol-Myers Squibb Holdings Ireland filed a lawsuit against a Russian manufacturer to suppress the threat of patent infringement by banning the introduction of the drug into civil circulation. It was about the drug dasatinib-nativ (INN dasatinib), intended for the treatment of chronic myeloid leukemia, specified in Nativ.

The Arbitration Court in the actions of the defendant did not see a violation of the exclusive rights of a foreign concern, as a result of which a decision was made to completely refuse to satisfy the claims.

Foreign companies do not abandon attempts to impede the activities of domestic manufacturers focused on import substitution, and use all available levers to put pressure on the making decisions of the department, - commented on the situation Alexander Malin, General Director of Nativa. As you know, Nativa is involved in litigation in a number of patent disputes with the largest multinational companies. At the same time, 6 of them have already been won.

Dependent Invention License

On June 1, 2018, the Moscow Arbitration Court granted the requirement of Nativa to issue a license to use the patent of Celgene Corporation due to the presence of a dependent invention, which Nativa plans to use in the production of a drug with INN lenalidomide. For the use of the patent "Nativa" will transfer license payments.

This is the first court decision to issue a license in connection with the presence of a dependent invention, despite the fact that the relevant rules on the procedure for granting such licenses have long been introduced into the Civil Code of the Russian Federation, - said Yulia Gerasimova, deputy general director of Nativa. - His conclusions will certainly have a strong influence on the further development of the practice of licensing the production of medicines in Russia. According to the position of the FAS Russia, copyright holders often abuse their position, and this greatly impedes the development of production and the supply of socially significant drugs in the Russian Federation.

Nativa proved through the court that the patent holder and the exclusive licensee of the dependent patent have every reason to obtain a license: the company's invention is an important technical achievement, and also has significant economic advantages over the development of the holder of the first patent, Nativa representatives explained.

Lenalidomide-native (INN Lenalidomide) is an antitumor immunomodulator used to treat leprosy, tuberculosis, AIDS, and multiple myeloma. Included in VED list. Registered in the State Register of Medicines on August 17, 2016. The Russian drug, according to the State Register of Marginal Prices, is more affordable in price than its American original.

Nativa beat R-Farm in three major disputes

Since April 20, 2018, Nativa has consistently won three major disputes over the collection of debts from R-Pharm, the total amount of which exceeded 400 million rubles. The latest dispute was ruled on May 24, 2018.

The first of the series of disputes won was the lawsuit on the claim for recovery from the defendant of more than 230 million rubles, unpaid under the contract for the supply of medicines from 2017. On April 20, the arbitration fully satisfied the plaintiff's claims. Also, through the court on April 27, Nativa recovered from R-Pharm more than 63 million rubles not paid under the supply contract. The last decision was made on May 24 to recover debts in the amount of more than 105 million rubles. The case is registered in the file of arbitration cases under the number A40-45108/18.

In addition to the three claims won, Nativa is awaiting consideration of two more cases to recover debts for 35 million and 190.2 million rubles, respectively. The first claim will be considered in a simplified proceeding, the company's lawyers expect a court decision no earlier than June 28. The court hearing on the second claim is scheduled for July 9 of this year.

"Nativa" won in a lawsuit with Bayer

The Arbitration Court of the Moscow Region decided to completely refuse the Bayer concern (Bayer HealthKer eLeLS, USA) to satisfy the claim against the Russian company Nativa to recognize and suppress the actions of violators of the plaintiff's exclusive rights. This was announced in Nativa on May 25, 2018.

The German concern, the manufacturer of the original drug Nexavar (INN Sorafenib), tried through the court to ban the pharmaceutical company Nativa from the manufacture, use, offer for sale, sale and storage of Sorafenib-nativ, and also claimed that the company violates the exclusive rights to the drug Nexavar, which is under patent protection.

As a third party, the defendant was involved in the consideration of the case. Ministry of Health Russia

The reason for the lawsuit against the Russian company was the fact of registration and subsequent launch of an analogue drug on the Nativa market. As stated in the lawsuit, the original medicine is under patent protection.

The Arbitration Court, having considered all the arguments of the parties, did not see in the defendant's actions a violation of the exclusive rights of a foreign concern and completely refused to satisfy the claims.

Vietnamese Pharmaceutical Market Exit Plan

In April 2018, the Russian company Nativa announced plans to enter the Vietnamese market.

"We can offer the Vietnamese market highly requested drugs for the treatment of cancer and broncho-pulmonary pathologies," said Alexander Malin, General Director of Nativa LLC.

The supply of Russian pharmaceutical products to Vietnam does not exceed $3 million, although trade between the countries is growing rapidly. Read more here.

Victory in court with AstraZenek Russia in the case of Formisonide-nativ

On February 28, 2018, the Moscow Region Arbitration Court decided to refuse Astraseneka Pharmaceuticals LLC to satisfy the claims against Nativa in the A41-90766/2017 case.

In November 2017, Astrazeneka Pharmaceuticals filed claims against Nativa LLC for recognition of the defendant's actions as unfair competition. The plaintiff stated that the defendant misled consumers, patients, medical specialists, government customers, as well as distributors regarding the consumer properties and quality of Formisonide-nativ, the first Russian generic drug for basic therapy of bronchial asthma.

The court also decided to refuse to satisfy the requirements for amending the documents contained in the registration dossier for Formisonide-native. As part of the court session, the operative part of the court decision was announced. Information on the adopted judicial act is published on the website of the Arbitration Court.

"Formisonide-nativ" is a combined drug for the basic therapy of bronchial asthma. The active ingredients budesonide and formoterol, due to different mechanisms of action, exhibit an additive effect on the pronounced symptoms of bronchial asthma, improving lung functions and reducing the frequency of exacerbations of diseases. The drug is used both as a maintenance therapy and to stop attacks, which allows you to control the disease, reduces treatment costs, improves the quality of life of patients.

Agreements on the supply of products to the countries of the Middle East and Asia

In February 2018, the pharmaceutical company Nativa announced the signing at Arab Health of a number of agreements with foreign distributors on the supply of Russian products to the countries of the Middle East and East Asia. The total amount of contracts exceeded $1.5 million.

The agreements were signed with such foreign players as Mongolian distributor Monos Pharma Trade LLC and Syrian company H Plus Pharma. In addition, agreements were reached on the supply of medicines with the Lebanese company Integrated Pharma Solutions (IPS). The first deliveries are planned to be implemented at the end of 2018.

Nativa agreed to supply Russian products to the countries of the Middle East and East Asia

Positive experience of mutually beneficial cooperation between Russia and Mongolia in the field of drug supply has already been accumulated. Interest in Russian pharmaceutical products is growing, and there are all prerequisites for increasing joint work. The supply of Nativa drugs will meet the needs of our market for antitumor drugs. We plan to develop our interaction and expand the presence of Nativa in the pharmaceutical market in Mongolia, - commented on the event in Monos Pharma Trade.

A contract has been signed with the Syrian distributor H Plus Pharma for the supply of the entire line of Nativa oncological drugs. We are talking about more than 20 names of drugs.

Syria is open to cooperation with Russia regarding the supply of pharmaceutical products. Such collaboration will help us ensure that vital drugs are available to a wide range of patients in the country. The Russian pharmaceutical industry, of course, has great potential in the Syrian market, according to H Plus Pharma.

In general, Nativa entered into agreements for the supply of its drugs to Syria and Mongolia, in addition, preliminary agreements were reached on supplies to Lebanon, Yemen and Jordan.

Our eastern partners are mainly interested in high-tech drugs for the treatment of rare (orphan) diseases, as well as antitumor drugs. "Nativa" has strong positions in these nosological niches, - said the general director of "Nativa" Alexander Malin.

2017: Plan to launch inhaler production in 2018

In November 2017, Nativa announced that it is the first manufacturer in Russia of multi-dose powder inhalation agents for the treatment of bronchopulmonary diseases - chronic obstructive pulmonary disease (COPD) and bronchial asthma, and that the company claims half of the domestic market for drugs of this group. Production will begin in 2018. This was announced by Alexander Malin, General Director of Nativa.

plan to launch the production of inhalers in September 2018. The company plans to reach 1.2-1.3 million packages in 2019, which will allow us to occupy at least half of the market by 2020, where only imported products are currently represented, "he said, adding that domestic inhalers will cost" at least 20% cheaper than their imported analogues. "

The volume of the multi-dose powder inhalers market in 2016, according to the company's analysts, amounted to 4.2 billion rubles.

"We are talking about the production of a full cycle - from the substance to the packaging of the finished dosage form," Zdrav.Expert was told in the company, specifying that the main feature of this type of inhaler in a blister tape, in which 60 doses of the drug are placed. This ensures that the dosage is accurate and the drug does not contact the environment until the time of use.

According to the Global Respiratory Inhalers Market report, which the manufacturer focuses on, chronic obstructive pulmonary disease (COPD) causes the death of about 3 million people a year, and up to 250 thousand people die from bronchial asthma annually. In Russia, 31.2 thousand people die from COPD, about 1.5 thousand more people a year from asthma.

2010: Founding of the Company

Nativa was founded in 2010.