Antivenom Production Busness Proposal

7/23/2019 Antivenom Production Busness Proposal

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Business Proposal

Developing Anti-Venomas a Snake Venom Cure



ANTIVENOMS

Antivenoms are the only efective specictreatments or antidotes or snakebite.

They are raised in large domestic animals(usually horses, donkeys or sheep) by

hyperimmunizing them against a single snakevenom (producing a monovalentmonospecic

antivenom) or against venoms o severalspecies o snakes !hose bites are common

and re"uently lead to severe envenoming inthe geographical area !here the particular

antivenom is intended to be used (producing apolyvalentpolyspecic antivenom).



PRODUCTION OF ANTIVENOMS

The venom o a single species o snake mayvary in composition and antigenicity.

As a result, pooled venom rom many (#$%&$)individual specimens o each snake species

should be used or antivenom production. These individuals should come rom diferent

parts o the geographical range and shouldinclude some younger (smaller) specimens to

take these actors into account. 'olyspecic and monospecic antivenoms



PRODUCTION OF ANTIVENOMS

Ater animals have completed the immunizationschedule, plasma is collected, preerably byplasmapheresis (so that the red blood cells can

be returned to the donor animal) and is passed

through several processes designed to produce

either rened !hole g antibodies or

g antibody ragments such as *(ab+)# or *ab, !hichare ree o other plasma proteins such as albumin,

ragments such as *c, aggregates (a maor cause oantivenom reactions), pyrogens and microbes.

t is then either lyophilized or stored as a li"uid.



Selection of snake venoms

the geographical region !here the antivenomis going to be used-

the medically most relevant snakes rom thegeographical region !here the antivenom is

going to be used- the variability o venom composition !ithin the

region o distribution o a snake species-

the inormation on cross%neutralization o

antivenoms against the venoms o species notincluded in the miture o venoms used toimmunize animals or antivenom manuacture.



USE OF ANTIVENIN

6

Antivenom neutralizes a ed amount ovenom. /ince snakes inect the same amount o

venom into adults and children, the same

dosevolume o antivenom must beadministered to children as to adults.

Antivenom can be efective as long as venom isstill active in the patient0s body causing

symptoms o systemic envenoming. These may persist or several days or even

!eeks ater the bite (e.g. incoagulable bloodand bleeding ater sa!%scaled viper bites).



INDICATIONS FOR ANTIVENOM

7

1hen used correctly,antivenin can efectivelyreverse systemic poisoning

Antivenin should not beadministered routinely in all

cases o snake bites as it cancause severe acute reactionsor atality.



Indications for antivenom treatmentafter bites by African snakes

Systemic envenoming 2. 3eurotoicity #. /pontaneous systemic bleeding 4. ncoagulable blood (#$5167T) 8. 7ardiovascular abnormality9 hypotension,

shock, arrhythmia, abnormal electrocardiogram

Local envenoming by species known tocause local necrosis* 2. :tensive s!elling (involving more than hal the

bitten limb) #. ;apidly progressive s!elling 4. 6ites on ngers and toes

*Bitis, Echis, Cerastes, Macrovipera spp. and spitting cobras



Sources of antivenom

There is great concern about the supply oantivenom or 3epal. /everal ndian producers, including /erum

nstitute o ndia (/), <ins 6ioproducts and 6harat/erum and <accines =td. (Asna Antivenom),

eport antivenoms to 3epal. The clinical e>cacy and saety o these

antivenoms needs to be established. 7onrm thatthe venoms used or their production are romArican and not Asian snake species.

6e!are o misleading labelling implying that theyhave activity against Arican rather than Asiancobra and sa!%scaled viper venoms



Product Background

? ndia, Thailand and 7hina earn largeamount o oreign currency through venomeports and that they had severalgovernment and private%run venom

production acilities.? :verest 6iotech can take initiatives toeport snake venom, a high%priced productin the international market.

? The proect !ould create employmentopportunities.



1ith the advancements in biomedicalsciences and technology, :verestbiotech !antto be the rst initiator by eporting snakevenom in other countries trough out the!orld.

1e already have ac"uired 7erticate omporter%:porter rom overnment o 3epalor antibody products and could getpermission or antivenin too.

1e can make collaboration !ith an authorizedovernment @ospital distributor inathmandu like TB Teaching and 6ir @ospital.



Mission

Cur mission is to bring to the market a highlyefective product range at economical prices,catering to every section o the society.

To provide international "uality

pharmaceutical and anti venom products.



Manufacturing and Production

The rst stage is theetraction and preparationo snake venom orimmunizing animals.

*or the second stage,there is the need orcountryside installations in!hich animals (goat orhorse) are maintained andimmunized according to aprescribed protocol so thatat the end a minimumre"uired antibody isobtained in the hyperimmune plasma.



Purification and QualityControl

n the third stage, the plasma istransported to the processing plantto obtain the nal product.

Duality control actions according to

recommendations o the WorldHealth Organization [WHO] are

included in this stage.

Also, or the !hole system,

availability o mice and guineapigs is needed to carry out the

activities o "uality control andsnake eeding.





Host animal

Anti venoms are typically produced using adonor animal, such as a horse or sheepor goat. The donor animal is hyper

immunized !ith non%lethal doses toproduce a neutralizing antibody response. Then, at certain intervals, the blood rom

the donor animal is collected and

neutralizing antibodies are puried rom theblood to produce anti venom. There is a Eo! diagram o a production

process, !hich is given in the ollo!ing

slide.



Wild Snake

Collect

Farm Branch Farm

Extraction of

venom

Venom

Store at 2

Celsius

Freeze-

drying

Weighing

acking

!istri"ution Storing



#$ES %F &%!'CE! ()#*VE)%+ &%!'C#S

SEC*ES S%'&CE %F#,E &%!'C#

1) Polyvalent Snake Anti venom Rattle Snake & Cobra.

2) Clot-Busting rug !"ite-li##e$ Pit %i#er

) Anti 'oral Coral Snake

() Snake %enom Antiserum Slen$er Coral Snake

) Bla'k Snake Anti venom Bla'k Ban$ Sea Snake

Types of Antivenin Products



Products Features



Different uses of the products

?

Stroke edicine% Foctors can use clot%busting drugs to treat stroke patients. 6utthese drugs have to be used !ithin threehours o the start o the stroke to beefective.

? !ancer"#ghting $roteins% 5ost cancers donot become deadly until they spread viablood vessels to ne! sites in the body. Thiscure can make it via 7lot%6usting Frug G/nake <enom Anti venom.

? Scaling %rain &isorders" Antielapidico canbe use to reduce the adverse efect o brainparalyzing as !ell as scaling o braindisorder.



Objectives

? To determine the impact o a nationallydeveloped snakebite treatment protocol on theamount o anti snake venom (A/<) used intreating snakebites in a developing country andits efect on mortality.

? To collect inormation on the availability o snakevenom or eporting as a cure in internationalmarket G the ultimate market analysis.

? To prove market%leading epertise in anti venomtreatment.

? To supply an array o pure and cost%efectiveproducts.? 1e are committed to !ork to!ards a healthier G

happier !orld.



Strengths

? Bnmatched product "uality? Association !ith trustedmanuacturers

? Cn%time delivery system? Team o eperienced proessionals? 5arket leading prices? :asy modes o payment? :thical business practices.? Cfering high "uality product.



Current Market Situation:

7urrent market situation represents relevant background data on sales, cost, prot, market,competitors, distributors and the total micro andmacro environment.

The marketing plan is constructed on the basis ocompetitors as !ell as our ne! strategies.

At present, the demand o anti%venom product isvery high. /o !e need to meet our local demandrst.

3ormally, venom o those snake can be stored ormany days. /o, !e can easily preserve them. t isvery cost efective also.



Benefits of our plan

t has been estimated snakes annually in /ri=anka bite I&$$$ people G snakebitesaccount or J$$%K$$ death rates is one othe highest in the !orld.

n 3epal, #4 districts rom terai and innerterai region have been reportingsnakebite case every year.

These patients rely on local herbal cures due

to the belie in the traditional system, easyaccess to traditional physicians, and theignorance o the availability o anti venom.



Benefits of our plan 3epal mainly import antivenin rom ndia. 6ut, the production o the antivenom in ndia is also

not the same like previous years. Animal rights activists in ndia has brought the

urther production o antivenom into a halt.

3epal sent letters to & diferent ndian companiesincluding Ha'kine (nstitute )or raining,+esearch and esting, Serum (nstitute o)(ndia, ,(-S %ioproducts Limited, SerumLimited, .ing (nstitute o) $reventive edicine / +esearch but Cnly one company gave interest

saying the price !ould be t!ice ie.;s 2,$&2 7onservative estimates suggest that there are

about #$, $$$ snake bites and 2$$$ atalities,almost all in the Tarai.



Risk and Constarins

'roducing 8$,$$$ vaccines investing more than;s &$$ million !ill be business o ailure andthus subsidies rom government are necessary.

The 3epal government has been providing theantivenom !ithout charge through 8# outlets

since #$$$ in #I districts. Thus it is di>cult to sale the products in 3epal

!ithout collaborating !ith 3epal overnment. /nake bite is /easonal in 3epal. The all the poisonous snakes o 3epal are not

completely kno!n. 5ost death is due tounkno!n snake bite.



Future Plan

1e could some plan in near uture tosupply the antivenin to 6angladesh, ndia,/ri =anka, 'akistan and Arica.



Resolutions 2. /nake and scorpion bites eist and need to be handled urgently

and competently. #.3eed or :pidemiological /urveys.

4.Training o @ealth 1orkers (nclusion in the 5edical 7urriculum).

8.3eed or individual country capacity building.

&. Address the issue o *A: and unsuitable antivenoms.

I. Loint procurement by countries in a given regional block rom one

regional producer to ensure price reduction.

J. *eedback meetings.

K. ntense 'harmacovigilance by relevant government authorities.

M. *unding or production or purchase o antivenoms through

subsidies.

2$. 7ollaboration !ith Traditional @ealers and more research into

their @erbal preparations



Conclusion

1e understand the dynamic market thatreceiving parties aces and recognize the uni"ueopportunity to obtain better product in betterprice.

1e believe that the speciy market o thisproduct is in its gro!th stage and that !e areuni"uely positioned to as a successul business.

1e are condent that our proposed services !illefectively address the needs.

1e are driven by a vision to ecel in the globalpharmaceutical industry and becomeunchallenged distributor o !orld%classpharmaceutical G anti%venomous treatmentproducts.



Thanks

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Antivenom Production Busness Proposal